Stent delivery device

ABSTRACT

A stent delivery device includes a distal-side tube having a guide wire lumen; a proximal-side tube whose distal portion is fixed to a proximal portion of the distal-side tube; a cylindrical member which encloses a distal side of the distal-side tube and is slidable toward a proximal end of the distal-side tube; a stent accommodated in the cylindrical member; and a pulling member  6  for moving the cylindrical member toward a proximal side of the stent delivery device. The distal-side tube has a proximal-side opening which is open at the proximal side of the distal-side tube; and a stent-locking portion for preventing the stent from moving to the proximal side of the stent delivery device. The outer diameter of the proximal-side tube is set smaller than that of a portion, having a maximum diameter, which is disposed in a region of the stent delivery device which is distal from the proximal-side tube.

BACKGROUND OF THE INVENTION

The present invention relates to a stent delivery device for implantinga stent at a stenosed portion or a closed portion generated in internalorgans such as a blood vessel, the bile duct the trachea, the esophagus,the ureter, a digestive tract, and the like.

Stent delivery devices proposed heretofore are used to secure a lumen ora space in a body cavity by implanting the stent at the lumen, thestenosed portion or the closed portion of the body cavity in an internalorgan such as the blood vessel, the bile duct, the trachea, theesophagus, the ureter, the digestive tract, and the like.

The stent is classified into a self-expandable stent and a balloonexpandable stent in dependence on the function thereof and animplantation method.

The balloon expandable stent which itself has no expanding function. Toimplant the stent at a desired portion, after the stent is inserted intothe desired portion, a balloon disposed in the stent is inflated toexpand (thermoplastically deform) the stent by an expansive force of theballoon so that the stent is fixed, with the stent in close contact withthe inner surface of the desired portion.

It is necessary to perform the above-described operation of expandingthe stent of this type in implanting it in the desired portion. Thestent can be implanted in the desired portion by directly mounting onthe contracted balloon. Thus the balloon expandable stent does not havea problem in this respect. But the stent does not have an expansiveforce by itself. Therefore there is a possibility that the diameter ofthe stent becomes smaller due to the pressure of the blood vessel withan elapse of time and that a constriction occurs again.

On the other hand, the self-expandable stent itself has contracting andexpanding functions. To implant the stent at a desired portion, after itis inserted into the desired portion in a contracted state, an appliedstress is released to maintain the contracted state. For example, thestent is accommodated in a sheath having a smaller diameter than theinner diameter of the desired portion by contracting the stent. Afterthe distal end of the sheath reaches the desired portion, the stent ispressed out of the sheath. Because the stent is released from thesheath, the applied stress is removed. Thereby the stent returns to theoriginal configuration. Thereby the stent adheres to the inner surfaceof the desired portion.

Unlike the balloon expandable stent, it is unnecessary to perform theoperation of expanding the stent of this type in implanting it in thedesired portion. Further there is no possibility that the diameter ofthe stent becomes smaller due to the pressure of the blood vessel andthat a constriction occurs again.

As compared with the balloon expandable stent, it is difficult toimplant the self-expandable stent correctly at the desired portion forthe reason described below. After the stent is disposed at a desiredstenosed portion, a liquid is injected into a balloon. Thus the stentdoes not move longitudinally when the stent is expanded. The deliverysystem of the self-expandable stent has a construction in which thestent is restrictedly accommodated between an inner tube and an outertube, and a locking portion for restricting the movement of the stent isprovided in the inner tube at a position located at the proximal side ofthe stent. By pulling the outer tube toward the proximal side of asystem, the stent is released from the restricted state and expandsitself. The stent is liable to move forward when it expands owing toloosening of the outer tube inside a body cavity and friction betweenthe stent and the body cavity, between the stent and a catheter orbetween the stent and a valve of a device called an introducer forintroducing the delivery system into a patients body.

In the system constructed of three tubular members described inWO96/31174, the outermost tube is provided in addition to the inner tubeand the outer tube. The stent is restrictedly accommodated between theinner tube and the outer tube, with the outermost tube and the innertube fixed outside the patients body. Thereby stent does not move. Inthis construction, there may be friction between the outermost tube andthe body cavity as well as the valve. But the outer tube is merelypulled to expand the stent. Therefore the stent hardly moves.

In the delivery system of the self-expandable stent proposed by thepresent applicant and described in JPA1996-252321, the stent littlemoves when the stent expands (discharged from system).

As the delivery system of the self-expandable stent, as described in theabove-described WO96/31174 and JPA1996-252321, an “over the wire type”in which the guide wire lumen extends from the proximal end of a systemto the distal end thereof. As the reason for the adoption of the “overthe wire type”, the construction of discharging the stent from theappliance necessitates the outer sheath to be moved to the proximal sideof the appliance.

When a plurality of stent delivery systems is prepared to implant thestent in the desired portion in the patient's body, systems havingdifferent outer diameters are used owing to a change of the outerdiameter of the stent caused by the expansion thereof. Thus after afirst stent delivery system is inserted into a blood vessel, it isexchanged with another system. In the “over the wire type”, the guidewire lumen is in penetration through the system from its distal end toits proximal end. To introduce the system into the patients body, theguide wire is required to be not less than twice as long as the entirelength of the system. Thus a long period of time is required to exchangethe systems.

Recently the stent is demanded to be implanted in peripheral portions inthe patient's body. Thus the development of a stent delivery systemhaving a small diameter is strongly demanded.

The system of WO96/31174 is difficult to have a small diameter becauseit uses three tubular members.

Therefore it is a first object of the present invention to provide astent delivery device, using a self-expandable stent, which facilitatesan operation of exchanging the stent delivery device with a differentstent delivery device in implanting a stent at a desired portion and hasa small diameter.

As described above, the delivery system of the self-expandable stent hasthe construction in which the stent is restrictedly accommodated betweenan inner tube and an outer tube, and a locking portion for restrictingthe movement of the stent is provided in the inner tube at the positionlocated at the proximal side of the stent. By pulling the outer tubetoward the proximal side of a stent delivery device, the stent isreleased from the restricted state and expands itself. At this time, itis necessary for an operator to fix the inner tube to a certain positionwith one hand to prevent a stent-implanted position from moving forwardand perform an operation of pulling the outer tube with the other hand.In implanting the stent in a bile duct through an endoscope, the innertube cannot be fixed to a certain position. Therefore the operatorperforms an operation of adjusting the stent-implanting position byexpanding the stent little by little and pulling the outer tube, withthe operator holding the endoscope with one hand. To solve such adisadvantage in operability, a system having a housing assembly has beendeveloped.

In US2004148009, the housing having the slider which can be moved inparallel is proposed. In this housing, the shaft is mounted inside thehousing, and the proximal end of the outer tube is connected with theslider longitudinally movable inside the housing. The stent is releasedby sliding the slider toward the proximal side of the system. Accordingto the description made in WO01/54614, the system can be operated withone hand. But actually in this system, it is necessary to use thehousing by fixing it to a hard surface fixed to an operating table or apatient's leg. Thus the system has a low operability and has apossibility that the implanting position of medical appliances are setat an unintended position. In addition, this system necessitates thehousing to be not less than twice as long as the entire length of theslider. Therefore the housing assembly is relatively large.

The housing assembly described in WO96/31174 has a construction similarto the above housing assembly and not less than two different operationmodes different in the operation speed thereof. This system alsonecessitates the housing to be not less than twice as long as the entirelength of the slider and thus the housing assembly to be relativelylarge. Therefore it is difficult to operate the system with one hand.

In the housing assembly disclosed in WO2002/087470, the proximal end ofthe outer tube is connected with the track inside the housing, and thetrack is gradually moved rearward by the ratchet means to therebyrelease the stent. The system can be operated with one hand. This systemalso necessitates the housing to be not less than twice as long as theentire length of the slider and thus the housing assembly to berelatively large.

Therefore it is a second object of the present invention to provide astent delivery device, using a self-expandable stent which facilitatesan operation of exchanging the stent delivery device with a differentstent delivery device in implanting a stent at a desired portion anddoes not move from an implanted position.

SUMMARY OF THE INVENTION

The first object described above is attained by the following a stentdelivery device.

A stent delivery device comprises a distal-side tube having a guide wirelumen; a proximal-side tube whose distal portion is fixed to a proximalportion of said distal-side tube; a cylindrical member which encloses adistal side of said distal-side tube and is slidable toward a proximalend of said distal-side tube; a stent housed in said cylindrical member;and a pulling wire which extends inside said proximal-side tube, withone end portion thereof fixed to said cylindrical member, wherein saiddistal-side tube has a proximal-side opening which is open at saidproximal side of said distal-side tube and communicates with said guidewire lumen; and a stent-locking portion which is disposed at said distalside of said distal-side tube and contacts a proximal end of said stent,thus preventing said stent from moving to said proximal side of saidstent delivery device; and said stent is formed approximatelycylindrically, housed in said cylindrical member, with said stent beingcompressed in an axial direction thereof, and expands outward andreturns to a configuration before said stent is compressed, when saidstent is implanted in an organism; said stent delivery device furthercomprising an operation portion, disposed at a proximal portion of saidproximal-side tube, which has a pulling wire winding mechanism forwinding said pulling wire and moving said cylindrical member toward aproximal side of said stent delivery device.

The second object described above is attained by the following a stentdelivery device.

A stent delivery device comprises a distal-side tube having a guide wirelumen; a proximal-side tube whose distal portion is fixed to a proximalportion of said distal-side tube; a cylindrical member which encloses adistal side of said distal-side tube and is slidable toward a proximalend of said distal-side tube; a stent housed in said cylindrical member;and a pulling member which extends inside said proximal-side tube, withone end portion thereof fixed to said cylindrical member and is pulledtoward said proximal side of said proximal-side tube to move saidcylindrical member toward a proximal side of said stent delivery device,wherein said distal-side tube has a proximal-side opening which is openat said proximal side of said distal-side tube and communicates withsaid guide wire lumen; and a stent-locking portion which is disposed atsaid distal side of said distal-side tube and contacts a proximal end ofsaid stent accommodated inside said cylindrical member, thus preventingsaid stent from moving to said proximal side of said stent deliverydevice; and said stent is formed approximately cylindrically,accommodated in said cylindrical member, with said stent beingcompressed in an axial direction thereof, and expands outward andreturns to a configuration before said stent is compressed, when saidstent is implanted in an organism; and

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partially schematic front view showing a stent deliverydevice of an embodiment of the present invention.

FIG. 2 is a partially schematic enlarged outlook view showing the stentdelivery device shown in FIG. 1.

FIG. 3 is an enlarged sectional view showing the neighborhood of adistal portion of the stent delivery device shown in FIG. 1.

FIG. 4 is an enlarged sectional view showing the neighborhood of aproximal portion of the stent delivery device shown in FIG. 1.

FIG. 5 is an outlook view showing an example of a stent accommodationcylindrical member for use in the stent delivery device of the presentinvention.

FIG. 6 is an enlarged sectional view taken along a line A-A of FIG. 2.

FIG. 7 is an enlarged sectional view taken along a line B-B of FIG. 2.

FIG. 8 is an enlarged sectional view showing the neighborhood of aproximal portion of a stent delivery device of another embodiment of thepresent invention.

FIG. 9 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 10 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention.

FIG. 11 is an enlarged sectional view showing the neighborhood of adistal portion of the stent delivery device shown in FIG. 10.

FIG. 12 is an explanatory view for explaining the operation of the stentdelivery device shown in FIG. 10.

FIG. 13 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention.

FIG. 14 is an enlarged sectional view taken along a line C-C of FIG. 13.

FIG. 15 is an enlarged sectional view taken along a line D-D of FIG. 13.

FIG. 16 is an enlarged outlook view showing a distal portion of a stentdelivery device of another embodiment of the present invention.

FIG. 17 is an enlarged outlook view showing a distal portion of a stentdelivery device of another embodiment of the present invention.

FIG. 18 is an enlarged sectional view showing the distal portion of thestent delivery device shown in FIG. 17.

FIG. 19 is an enlarged outlook view showing a distal portion of a stentdelivery device of another embodiment of the present invention.

FIG. 20 is a sectional view taken along a line E-E of FIG. 19.

FIG. 21 is an enlarged sectional view taken along a line F-F of FIG. 19.

FIG. 22 is an enlarged sectional view taken along a line G-G of FIG. 19.

FIG. 23 is a perspective view showing a stent, to be implanted in alumen, for use in the stent delivery device of the present invention.

FIG. 24 is a partially schematic front view showing a stent deliverydevice of an embodiment of the present invention.

FIG. 25 is an enlarged outlook view showing the neighborhood of a distalportion of the stent delivery device shown in FIG. 24.

FIG. 26 is an enlarged sectional view showing the neighborhood of thedistal portion of the stent delivery device shown in FIG. 24.

FIG. 27 is an enlarged outlook view showing the neighborhood of anoperation portion of the stent delivery device shown in FIG. 24.

FIG. 28 is an enlarged sectional view taken along a line H-H of FIG. 25.

FIG. 29 is an enlarged sectional view taken along a line I-I of FIG. 25.

FIG. 30 is a right-hand side view showing the neighborhood of theoperation portion of the stent delivery device shown in FIG. 24.

FIG. 31 is a bottom view showing the operation portion of the stentdelivery device shown in FIG. 24.

FIG. 32 is an enlarged sectional view taken along a line J-J of FIG. 30.

FIG. 33 is an enlarged sectional view taken along a line K-K of FIG. 32.

FIG. 34 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 35 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 36 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 37 is a schematic enlarged outlook view showing a neighborhood ofthe distal portion of the stent delivery device of another embodiment ofthe present invention.

FIG. 38 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention.

FIG. 39 is an enlarged sectional view taken along a line L-L of FIG. 38.

FIG. 40 is an enlarged sectional view taken along a line M-M of FIG. 38.

FIG. 41 is an enlarged outlook view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention.

FIG. 42 is an enlarged sectional view showing the neighborhood of theoperation portion of the stent delivery device shown in FIG. 41.

FIG. 43 is an explanatory view for explaining an internal constructionof the neighborhood of an operation portion of the stent delivery deviceshown in FIG. 41.

FIG. 44 is a partially schematic front view showing a stent deliverydevice of an embodiment of the present invention.

FIG. 45 is an enlarged outlook view showing the neighborhood of theoperation portion of the stent delivery device shown in FIG. 44.

FIG. 46 is an enlarged left-hand side view showing the neighborhood ofthe operation portion of the stent delivery device shown in FIG. 44.

FIG. 47 is an enlarged bottom view showing the operation portion of thestent delivery device shown in FIG. 44.

FIG. 48 is a sectional view taken along a line O-O of FIG. 46.

FIG. 49 is an enlarged sectional view taken along a line P-P of FIG. 48.

FIG. 50 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 51 is an explanatory view for explaining the operation of the stentdelivery device of the present invention.

FIG. 52 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention.

FIG. 53 is an enlarged front view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention.

FIG. 54 is a left-hand side view showing the neighborhood of theoperation portion of the stent delivery device shown in FIG. 53.

FIG. 55 is an enlarged front view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention.

FIG. 56 is a rear side view showing the neighborhood of the operationportion of the stent delivery device shown in FIG. 55.

FIG. 57 is an explanatory view for explaining an internal constructionof the neighborhood of an operation portion of the stent delivery deviceshown in FIG. 55.

FIG. 58 is an explanatory view for explaining the internal constructionof the neighborhood of the operation portion of the stent deliverydevice shown in FIG. 55.

FIG. 59 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention.

FIG. 60 is an enlarged sectional view showing the neighborhood of adistal portion of the stent delivery device shown in FIG. 59.

FIG. 61 is an enlarged sectional view taken along a line Q-Q of FIG. 59.

FIG. 62 is an enlarged front view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention.

FIG. 63 is an explanatory view for explaining an internal constructionof the neighborhood of the operation portion of the stent deliverydevice shown in FIG. 62.

FIG. 64 is an explanatory view for explaining an internal constructionof the neighborhood of the operation portion of the stent deliverydevice shown in FIG. 62.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The embodiments of the stent delivery device of the present inventionwill be described below with reference to the drawings.

A stent delivery device 1 of the present invention includes adistal-side tube 2 having a guide wire lumen 21; a proximal-side tube 4whose distal portion is fixed to a proximal portion of the distal-sidetube 2; a cylindrical member (in other words, stent accommodationcylindrical member) 5 which encloses a distal side of the distal-sidetube 2 and is slidable toward a proximal end of the distal-side tube 2;a stent 3 housed (in other words, accommodated) in the stentaccommodation cylindrical member 5; and a pulling member 6 which extendsinside the proximal-side tube 4, with one end portion thereof fixed tothe stent accommodation cylindrical member 5 and is pulled toward theproximal side of the proximal-side tube 4 to move the stentaccommodation cylindrical member 5 toward a proximal side of the stentdelivery device 1.

The distal-side tube 2 has a proximal-side opening 23 which is open atthe proximal side of the distal-side tube 2 and communicates with theguide wire lumen 21; and a stent-locking portion 22 which is disposed atthe distal side of the distal-side tube 2 and contacts a proximal end ofthe stent 3 accommodated inside the stent accommodation cylindricalmember 5, thus preventing the stent 3 from moving to the proximal sideof the stent delivery device. The stent 3 is formed approximatelycylindrically and accommodated in the stent accommodation cylindricalmember 5, with the stent 3 being compressed in an axial directionthereof. The stent 3 expands outward and returns to a configurationbefore the stent is compressed, when the stent is implanted in anorganism. The outer diameter of the proximal-side tube 4 is set smallerthan that of a portion, having a maximum diameter, which is disposed ina region of the stent delivery device 1 distal from the proximal-sidetube 4.

According to the stent delivery device of the present invention using aself-expandable stent the opening at the proximal side thereof isdisposed not at the proximal end thereof, but at the proximal side ofthe distal-side tube. Therefore in a stent-implanting operation, it iseasy to perform an operation of exchanging the stent delivery devicewith a stent delivery device of other types. The outer diameter of theproximal-side tube is set smaller than that of the portion, having themaximum diameter, which is disposed in the region of the stent deliverydevice 1 distal from the proximal-side tube 4. Therefore even in a statein which the guide wire is extended along the side surface of theproximal-side tube from the opening at the proximal side of the stentdelivery device to the proximal side of the stent delivery device, theouter diameter of the proximal-side tube is set almost equally to thatof the portion, having the maximum diameter, which is disposed in theregion of the stent delivery device distal from the proximal-side tube.Thereby the stent can be inserted into a narrow blood vessel.

The stent delivery device of this embodiment has the distal-side tube 2;the proximal-side tube 4; the stent accommodation cylindrical member 5;the stent 3; and the pulling member 6.

The stent delivery device 1 of this embodiment has an intermediate tube7 which encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 and isfixed at the proximal portion thereof to the proximal portion of thedistal-side tube 2 and the distal portion of the proximal-side tube 4.In the stent delivery device 1 of this embodiment, the intermediate tube7 encloses the proximal side of the distal-side tube 2 and the proximalside of the stent accommodation cylindrical member 5 without preventingthe stent accommodation cylindrical member 5 from moving toward theproximal side of the stent delivery device 1. One end portion of thepulling member 6 is fixed to the stent accommodation cylindrical member5 inside the intermediate tube 7. The pulling member 6 passes a spacebetween the intermediate tube 7 and the distal-side tube 2 and extendsinto the proximal-side tube 4. Thereby the pulling wire is not exposed.

As shown in FIGS. 1, 2, 3, and 5, the stent accommodation cylindricalmember 5 is tubular having a predetermined length. The stentaccommodation cylindrical member 5 is open at its distal end andproximal end. When the stent 3 is implanted in a stenosed portion of alumen, the opening of the stent accommodation cylindrical member 5 atits distal end functions as a discharge opening. By being pressed out ofthe opening of the stent accommodation cylindrical member 5 at itsdistal end, a stress applied to the stent 3 is released and expands,thus returning to a configuration before it is compressed.

The length of the stent accommodation cylindrical member 5 is favorablyin the range of 20 mm to 400 mm and more favorably in the range of 30 mmto 250 mm. The outer diameter of the stent accommodation cylindricalmember 5 is favorably in the range of 11.0 mm to 4.0 mm and morefavorably in the range of 1.5 mm to 3.0 mm. The inner diameter of thestent accommodation cylindrical member 5 is favorably in the range of1.0 to 2.5 mm. In the stent accommodation cylindrical member 5 of thisembodiment, the stent accommodation portion disposed at the distal sidethereof is set as a large-diameter portion 51, whereas the proximal sidethereof is set as a small-diameter portion. The outer diameter of thelarge-diameter portion is favorably in the range of 1.0 to 4.0 mm andmore favorably in the range of 1.5 to 3.0 mm. The outer diameter of thesmall-diameter portion is favorably in the range of 1.0 to 4.0 mm andmore favorably in the range of 1.2 to 2.8 mm. The stent accommodationcylindrical member 5 may have the same outer diameter over the wholelength thereof.

As shown in FIGS. 2, 3, 5, and 6, the stent accommodation cylindricalmember 5 has a slit 52 extending from the proximal end thereof to thedistal side thereof. A projected portion (in this embodiment, tubularmember 8 through which pulling member penetrates) formed on the outersurface of the distal-side tube 2 is capable of moving into the slit 52.The projected portion will be described later. In this embodiment, untilthe distal end of the slit 52 contacts the tubular member 8, the stentaccommodation cylindrical member 5 is movable toward the proximal sideof the stent delivery device. Thus the length of the slit 52 is setequally to or a little longer than a length in the range from theproximal end of the stent 3 accommodated in the stent accommodationcylindrical member 5 to the distal end of the stent accommodationcylindrical member 5.

Materials for forming the stent accommodation cylindrical member 5, thefollowing materials are preferable in consideration of the property(flexibility, strength, sliding property, kink resistance, andstretching property) demanded for the stent accommodation cylindricalmember are selected appropriately from the following substances:polyethylene, polypropylene, nylon, polyethylene terephthalate; andfluorine-containing polymer such as PTFE, ETFE; and thermoplasticelastomer. The thermoplastic elastomer is selected from among nylonfamily (for example, polyamide elastomer), urethane family (for example,polyurethane elastomer), polyester family (for example, polyethyleneterephthalate elastomer), olefin family (for example, polyethyleneelastomer, polypropylene elastomer).

It is preferable to treat the outer surface of the stent accommodationcylindrical member 5 so that the outer surface thereof displayslubricity. For example, hydrophilic polymers are applied to the outersurface thereof or fixed thereto: As the hydrophilic polymers, it ispossible to use poly(2-hydroxyethyl methacrylate), polyhydroxyethylacrylate, hydroxypropyl cellulose, copolymer of methyl vinyl ether andmaleic anhydride, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone. The above-described substances may be applied or fixed tothe inner surface of the stent accommodation cylindrical member 5 toenhance slidability.

The stent 3 is accommodated in the stent accommodation cylindricalmember 5 at the distal portion thereof. The stent 3 is a so-calledself-expandable stent. More specifically, the stent 3 is formedapproximately cylindrical. When the stent 3 is inserted into anorganism, the stent 3 is compressed in the axial direction thereof. Whenthe stent 3 is implanted in the organism, the stent 3 expands outwardand returns to a configuration before it is compressed. The stent 3 isheld inside the stent accommodation cylindrical member 5, with the stent3 being compressed in the axial direction thereof. Thus the stent 3 isheld inside the stent accommodation cylindrical member 5, with the stent3 pressing the inner surface of the stent accommodation cylindricalmember 5 by a restoring force thereof. As described later, thestent-locking portion 22 provided inside the distal-side tube 2 preventsthe stent 3 from moving toward the proximal side of the stent deliverydevice.

As the stent 3, it is possible to use the self-expandable stent of anytypes. For example, it is possible to preferably use the stent 3 havinga configuration shown in FIG. 23 (showing a state in which by itsself-expansion, stent returns to a configuration before it iscompressed). The stent 3 of this example has a cylindrical frame body 3a, openings 34 partitioned (surrounded) from one another with frames 36a, 36 b constructing the cylindrical frame body 3 a, and cut-outportions 35 partitioned from one another with the frames 36 a. The framebody 3 a has both ends 33 a, 33 b.

As the material for forming the stent, synthetic resin or metal is used.Synthetic resin having a proper degree of hardness and elasticity isused. Synthetic resin compatible with organisms is preferable. Forexample, polyolefins (for example, polyethylene, polypropylene),polyester (for example, polyethylene terephthalate), fluororesin (forexample, PTFE, ETFE), polylactic acid, polyglicolic acid, and copolymerof polylactic acid and polyglicolic acid which is absorbed intoorganisms. Metal compatible with organisms is preferable. For example,stainless steel, tantalum, nickel-titanium alloy. Super-elastic metal isespecially preferable. It is preferable that the stent 3 is formedintegrally without change points at which property changes rapidly beingformed therein. The stent is formed by preparing a metal pipe having anouter diameter suitable for a desired portion in an organ at which thestent is implanted, removing a part of the side surface of the metalpipe by means of cutting work (for example, mechanical cutting, lasermachining), chemical etching or the like, and forming a plurality ofcut-out portions or openings on the side surface thereof.

Because the stent 3 has the cut-out portions 35 at the ends of the framebody 3 a, the ends 33 a, 33 b of the stent 3 deform easily. The ends 33a, 33 b are capable of partly deforming. Thereby the stent 3 has afavorable response to deformation of a blood vessel in which the stent 3is implanted. Because the ends 33 are formed of the ends of a pluralityof the frames 36 a, the stent 3 is not broken easily and thus has asufficient strength. The openings 34 surrounded with the frames 36 a, 36b are formed between both ends 33 a, 33 b and deform easily by thedeformation of the frame 36 a. Thus the stent 3 deforms easily at itscentral portion (central portion of the frame body 3 a). Neither thenumber of the cut-out portions and that of the openings are not limitedto those shown in FIG. 23 nor the configuration of the cut-out portionsand that of the openings is limited to those shown in FIG. 23. Thenumber of the cut-out portions is set to preferably 3 to 10. The numberof the openings is set to preferably 3 to 10.

The outer diameter of the frame body 3 a is favorably in the range of2.0 mm to 30 mm and more favorably in the range of 2.5 mm to 20 mm. Theinner diameter of the frame body 3 a is favorably in the range of 1.4 mmto 29 mm and more favorably in the range of 1.6 mm to 28 mm. The lengthof the frame body 3 a is favorably in the range of 10 to 150 mm and morefavorably in the range of 15 to 100 mm.

The configuration of the stent is not limited to the one shown in FIG.23. For example, the stent may have trapezoidal cut-out portions formedat both ends thereof and a plurality of hexagonal openings formed at thecentral portion thereof. As another example, the stent may haverectangular cut-out portions at both ends thereof and a plurality ofrectangular (twice as long as length of cut-out portion) openings formedat the central portion thereof. As still another example, it is possibleto use the stent of configurations other than the above-described one solong as it can be decreased in its diameter when it is inserted into adesired portion of an organ and restored to its original state when itreaches the desired portion thereof. For example, it is possible to usethe stent coiled, cylindrical, roll-shaped, odd-shaped tubular,higher-order coil-shaped, leaf spring-like, basket-shaped, andmesh-shaped.

Super-elastic alloys can be preferably used as the super-elastic metalforming the stent. Herein the super-elastic alloy means a so-calledshape memory alloy that shows super-elasticity essentially at thetemperature (in the vicinity of 37° C.) of the organism. The followingsuper-elastic metals can be favorably used: A Ti—Ni alloy of 49-53atomic percent of Ni, a Cu—Zn alloy of 385-415 wt % of Zn, a Cu—Zn—Xalloy of 1-10 wt % of X (X=Be, Si, Sn, Al, Ga), and a Ni—Al alloy of36-38 atomic percent of Al. The Ti—Ni alloy is most favorable. Themechanical characteristic of the Ti—Ni alloy can be appropriatelychanged by replacing a part of the Ti—Ni alloy with 0.01-10.0% of X toobtain a Ti—Ni—X alloy (X=Co, Fe, Mn, Cr, V, Al, Nb, W, B and the like)or by replacing apart of the Ti—Ni alloy with 0.01-30.0 atomic percentof X to obtain a Ti—Ni—X alloy (X=Cu, Pb, Zr). Further the mechanicalcharacteristic of the super-elastic alloy can be appropriately changedby selectively adopting a cold working ratio or/and the condition offinal heat treatment. Furthermore the mechanical characteristic of thesuper-elastic alloy can be appropriately changed by using the Ti—Ni—Xalloy and selectively adopting a cold working ratio or/and the conditionof final heat treatment.

The buckling strength (yield stress when load is applied to stent) ofthe super-elastic alloy to be used is favorably in the range of 5-200kg/mm² (22° C.) and more favorably in the range of 8-150 kg/mm². Therestoring stress (yield stress when load is eliminated from stent) ofthe super-elastic alloy is favorably in the range of 3-180 kg/mm² (22°C.) and more favorably in the range of 5-130 kg/mm². Thesuper-elasticity means that when a metal is deformed (bent, stretched,compressed) to a region in which it deforms plastically at a servicetemperature, it returns to its original configuration substantiallywithout heating it after an applied load is eliminated.

The stent to be used in the stent delivery device of the presentinvention may have a diameter-reducible body formed approximatelycylindrically and a cylindrical cover (not shown) sealing the sidesurface of the body.

As shown in FIGS. 1 through 3, the distal-side tube 2 is a tubular bodyhaving the guide wire lumen 21 penetrating through the distal-side tube2 from its distal end to its proximal end. The distal-side tube 2 has adistal portion formed by a distal-end member 25 fixed to the distal endthereof and has a distal-end opening 24. The distal portion formed bythe distal-end member 25 may be formed integrally with the distal-sidetube 2. The proximal end of the distal-side tube 2 is fixed to thedistal end of the proximal-side tube. The stent delivery device has theproximal-side opening 23 at the proximal portion (proximal end in thisembodiment) of the distal-side tube 2. As shown in FIG. 3, the proximalportion of the distal-side tube 2 is curved. As shown in FIGS. 3 and 7,the proximal-side opening 23 is formed obliquely so that it inclinestoward the proximal side of the stent delivery device. Thereby it iseasy to guide the guide wire.

As shown in the drawings, the distal-side tube 2 is a tubular bodyhaving the guide wire lumen 21 penetrating the distal-side tube 2 fromits distal end to proximal end. The outer diameter of the distal-sidetube 2 is favorably in the range of 0.3 to 2.0 mm and more favorably inthe range of 05 to 15 mm. The inner diameter of the distal-side tube 2is favorably in the range of 0.2 to 1.5 mm and more favorably in therange of 0.3 to 1.2 mm. The length of the distal-side tube 2 isfavorably in the range of 20 to 600 mm and more favorably in the rangeof 30 to 350 mm.

It is preferable that the distal-end member 25 is disposed at the sidedistal from the distal end of the stent accommodation cylindrical member5 and tapered toward its distal end to gradually decrease its diameter,as shown in FIG. 3. This configuration facilitates insertion of thestent delivery device into the stenosed portion. It is preferable thatthe distal-side tube 2 is provided with a stopper, disposed at the sidedistal from the stent 3, for preventing a movement of the stentaccommodation cylindrical member 5 toward the distal end of the stentdelivery device. In this embodiment, the proximal end of the distal-endmember 25 is capable of contacting the distal end of the stentaccommodation cylindrical member 5 and functions as the above-describedstopper.

The outer diameter of the distal end of the distal-end member 25 ispreferably in the range of 0.5 to 1.8 mm. The outer diameter of thedistal-end member 25 at a portion thereof having the maximum diameter ispreferably in the range of 0.8 to 4.0 mm. The length of the tapereddistal-end member 25 is preferably in the range of 2.0 to 20.0 mm.

As shown in FIG. 3, the distal-side tube 2 has the stent-locking portion22 for preventing the stent 3 to be implanted in an organism from movingto the proximal side thereof. It is preferable that the stent-lockingportion 22 is formed as an annular projected portion. The portion of thedistal-side tube 2 distal from the stent-locking portion is formed as astent accommodation portion. The outer diameter of the stent-lockingportion 22 is so set that the stent-locking portion 22 is capable ofcontacting the proximal end of the compressed stent 3. When the stentaccommodation cylindrical member 5 moves to the proximal side of thestent delivery device, the stent-locking portion 22 keeps the positionof the stent 3. Thereby the stent 3 is discharged from the stentaccommodation cylindrical member 5.

It is preferable that the outer diameter of the stent-locking portion 22is in the range of 0.8 to 4.0 mm. It is preferable that thestent-locking portion 22 is formed as an annularly projected portion, asshown in the drawing. Provided that the stent-locking portion restrictsthe movement of the stent 3 and is capable of pressing the stent 3 outof the stent delivery device, the stent-locking portion may be formedintegrally with the distal-side tube 2 or as one or a plurality ofprojections separate from the distal-side tube. In addition, thestent-locking portion 22 may be made of an x-ray contrast materialseparate from the distal-side tube. Thereby the position of the stentcan be accurately grasped, and maneuver can be accomplished easily. Asthe x-ray contrast material, gold, platinum, platinum-iridium alloy,silver, stainless steel, and alloys of these metals are used. To formthe projected portion as the stent-locking portion, a wire made of thex-ray contrast material is wound around the outer surface of the innertube or a pipe made of the x-ray contrast material is caulked or bondedto the outer surface of the inner tube.

As the material for forming the distal-side tube, materials having aproper degree of hardness and flexibility can be preferably used. Thusthe following substances are used: polyolefins such as polyethylene,polypropylene; polyamide; polyester such as polyethylene terephthalate;fluorine-containing polymer such as ETFE; PEEK (polyether ether ketone),and polyimide. Of the above-described resin, thermoplastic resin ispreferable. Resin compatible with organisms and especiallythrombosis-resistant may be applied to the outer surface of thedistal-side tube exposed to the outside. The followingthrombosis-resistant substances can be preferably used: polyhydroxyethylmethacrylate, hydroxyethyl methacrylate-styrene copolymers (for example,HEMA-St-HEMA block copolymer).

When the distal-end member is composed of a material separate from thatof the tube, it is preferable to use the following flexible materials:synthetic resin elastomers such as olefin elastomers (for example,polyethylene elastomer, polypropylene elastomer), polyamide elastomer,styrene elastomers, (for example, styrene-butadiene-styrene copolymer,styrene-isoprene-styrene copolymer, styrene-ethylene-butylene-styrenecopolymer); polyurethane, urethane elastomers, fluororesin elastomers;rubbers including synthetic rubber such as urethane rubber, siliconerubber, butadiene rubber, and natural rubber such as Latex rubber.

As shown in FIGS. 2, 4, and 7, the proximal-side tube 4 is a tubularbody extending from its distal end to proximal end. The proximal-sidetube 4 has a hub 12 fixed to its proximal end. The distal portion of theproximal-side tube 4 is joined with the proximal portion of thedistal-side tube 2. The proximal-side tube 4 has therein a lumen 41 intowhich the pulling member 6 can be inserted.

The length of the proximal-side tube 4 is favorably in the range of 300to 1500 mm and more favorably in the range of 1000 to 1300 mm. The outerdiameter of the proximal-side tube 4 is favorably in the range of 0.5 to1.5 mm and more favorably in the range of 0.6 to 1.3 mm. The innerdiameter of the proximal-side tube 4 is favorably in the range of 0.3 to1.4 mm and more favorably in the range of 0.5 to 1.2 mm.

The outer diameter of the proximal-side tube 4 is set shorter than thatof the intermediate tube which is described later by favorably 0.1 to2.5 mm and more favorably 0.3 to 1.5 mm.

The outer diameter of the proximal-side tube 4 is set smaller than thatof the portion, having a maximum diameter, which is disposed in theregion of the stent delivery device 1 distal from the proximal-side tube4. More specifically, in this embodiment the outer diameter of theproximal-side tube 4 is set smaller than the maximum outer diameter ofthe portion where the distal-side tube 2 and the proximal-side tube 4are fixed to each other. It is preferable that the outer diameter of theproximal-side tube is smaller than that of the stent accommodationcylindrical member 5. As shown in FIGS. 2, 3, and 7, in this embodiment,the distal portion of the proximal-side tube 4 is fixed to the proximalportion of the distal-side tube 2 by shifting the axis of theproximal-side tube 4 in a direction away from the proximal-side opening23 with respect to the axis of the distal-side tube 2. Therefore bydisposing the guide wire extended from the proximal-side opening 23along the outer surface of the proximal-side tube 4 which is theextension of the proximal-side opening 23, it is possible to decreasethe outer diameter of the stent delivery device 1 at its distal sideincluding the guide wire. Thus it is possible to make the operability ofthe guiding wire favorable inside a guide catheter which is used in anoperation and use the guiding catheter having a small diameter.

The interval between the axis of the proximal-side tube 4 and that ofthe distal-side tube 2 is in the range of favorably 0.1 to 2.0 mm andmore favorably 05 to 1.5 mm.

As the material for forming the proximal-side tube, it is preferable touse materials having a proper degree of hardness and flexibility. Thefollowing substances can be preferably used: polyolefins such aspolyethylene, polypropylene; nylon, polyethylene terephthalate;fluorine-containing polymer such as ETFE; PEEK (polyether ether ketone),and polyimide. Resin compatible with organisms and especiallythrombosis-resistant may be applied to the outer surface of thedistal-side tube. The following thrombosis-resistant substances can bepreferably used: polyhydroxyethyl methacrylate, hydroxyethylmethacrylate-styrene copolymers (for example, HEMA-St-HEMA blockcopolymer). As the material for forming the proximal-side tube, it ispreferable to use materials having a comparatively high rigidity. It ispossible to use metal such as Ni—Ti, brass, stainless steel, aluminum,and the like; and resin having a comparatively high rigidity such aspolyimide, vinyl chloride, polycarbonate, and the like.

The stent delivery device 1 of this embodiment has the intermediate tube7 which encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 and isfixed at the proximal portion thereof to the proximal portion of thedistal-side tube 2 and the distal portion of the proximal-side tube 4.In the stent delivery device 1 of this embodiment, the intermediate tube7 encloses the proximal side of the distal-side tube 2 and the proximalside of the stent accommodation cylindrical member 5 without preventingthe stent accommodation cylindrical member 5 from moving toward theproximal side of the stent delivery device 1. One end portion of thepulling member 6 is fixed to the stent accommodation cylindrical member5 inside the intermediate tube 7. The pulling member 6 passes the gapbetween the intermediate tube 7 and the distal-side tube 2 and extendsinto the proximal-side tube 4. Thereby the pulling wire is not exposed.

The proximal portion of the distal-side tube 2 extends inside theintermediate tube 7 and is exposed from the proximal end of theintermediate tube 7. The distal portion of the proximal-side tube 4penetrates into the proximal portion of the intermediate tube 7. Thedistal-side tube 2, the proximal-side tube 4, and the intermediate tube7 are liquid-tightly fixed to the proximal portion of the intermediatetube 7. The lumen 4 inside the proximal-side tube 4 communicates withthe inside of the intermediate tube 7. As shown in FIGS. 2 and 3, thedistal portion of the intermediate tube 7 is decreased in its diameteror curved. It is preferable that the distal end of the intermediate tube7 liquid-tightly contacts the outer surface of the stent accommodationcylindrical member 5 without preventing the movement of the stentaccommodation cylindrical member 5. But the distal end of theintermediate tube 7 does not necessarily have to contact the outersurface of the stent accommodation cylindrical member 5.

As the material for forming the intermediate tube, it is preferable touse materials having a proper degree of hardness and flexibility. Thefollowing substances can be preferably used: polyolefins such aspolyethylene, polypropylene; nylon, polyethylene terephthalate;fluorine-containing polymer such as ETFE; PEEK (polyether ether ketone),and polyimide. Of the above-described resin, thermoplastic resin ispreferable. Resin compatible with organisms and especiallythrombosis-resistant may be applied to the outer surface of theintermediate tube. The following thrombosis-resistant substances can bepreferably used: polyhydroxyethyl methacrylate, hydroxyethylmethacrylate-styrene copolymers (for example, HEMA-St-HEMA blockcopolymer).

The stent delivery device 1 has the pulling member 6 extending insidethe proximal-side tube 4, with one end portion thereof fixed to thestent accommodation cylindrical member 5. The pulling member 6 is pulledtoward the proximal side of the proximal-side tube 4 to move the stentaccommodation cylindrical member 5 toward the proximal side of the stentdelivery device 1.

In the stent delivery device 1 of this embodiment, the pulling member 6is composed of a pulling wire. As shown in FIGS. 1, 2, and 4, thepulling member 6 penetrates through the proximal-side tube 4 and extendsto the outside from the proximal end of the proximal-side tube 4.

A twisted wire material or a plurality of twisted wire materials can bepreferably used as the material for composing the pulling wire. Thediameter of the pulling wire is in the range of favorably 0.01 to 0.55mm and more favorably 0.1 to 03 mm.

As the material for forming the pulling member 6, the followingsubstances can be used: stainless steel wire (preferably, high tensilestainless wire for spring); music wire (preferably, nickel-plated orchromium-plated music wire); super-elastic alloy wire; wires made ofmetal such as Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungstenalloy, titanium, titanium alloy, cobalt alloy; tantalum, comparativelyhigh rigidity polymeric materials such as polyamide, polyimide,ultra-high-molecular-weight polyethylene, polypropylene, andfluororesin; and combinations of these substances.

Resin having low frictional property which increases lubricity may beapplied to the side surface of the pulling member. As the resin havinglow frictional property, it is possible to use fluororesin, nylon 66,polyether ether ketone, high-density polyethylene, and the like. Aboveall, the fluororesin is particularly favorable. As the fluororesin,polytetrafluoroethylene, polyvinylidene fluoride,ethylenetetrafluoroethylene, perfluoroalkoxy resin, and the like arepreferable. The side surface of the pulling member may be coated withsilicone or hydrophilic resin.

An operating member 53 fixed to the proximal portion of the pullingmember 6 is so formed as to enclose the proximal portion of the pullingmember 6 and a bulged portion formed at the proximal end thereof. Theoperating member 53 of this embodiment has a through-hole 54 into whicha finger or the like can be inserted.

The stent delivery device 1 of this embodiment has the projected portion(in this embodiment, tubular member though which wire penetrates) 8provided on the outer surface of the distal-side tube 2 at its proximalside. The projected portion 8 is capable of moving inside the slit 52 ofthe stent accommodation cylindrical member 5. The distal end of theprojected portion 8 is disposed inside the proximal portion of the slit52. The projected portion 8 prevents the stent accommodation cylindricalmember 5 from rotating on the axis thereof when the stent deliverydevice 1 is operated. Because the slit 52 extends toward the distal sideof the stent delivery device, the slit 52 guides a linear movement forthe stent accommodation cylindrical member 5 without preventing themovement of the stent accommodation cylindrical member 5 toward theproximal side of the stent delivery device. The projected portion (inthis embodiment, tubular member though which wire penetrates) 8 is fixedto the outer surface of the distal-side tube 2, but may be fixed to theinner surface of the intermediate tube 7. The projected portion 8 may beextended from the distal end of the proximal-side tube to the distalside thereof. The stent delivery device 1 of this embodiment has amovement distance restriction portion for restricting a movementdistance of the stent accommodation cylindrical member 5 toward theproximal side of the stent delivery device. More specifically, owing tothe movement of the stent accommodation cylindrical member 5 toward theproximal side of the stent delivery device, the projected portion (inthis embodiment tubular member though which wire penetrates) 8 contactsthe distal end of the slit 52, thus preventing a further movement of thestent accommodation cylindrical member 5 toward the proximal side of thestent delivery device.

The stent delivery device 1 of this embodiment has a member for holdingthe position of the pulling member. This member is disposed on the outersurface of the distal-side tube 2 and has a passage through which thepulling member 6 is capable of penetrating. The stent delivery device ofthis embodiment has a tubular member 8 displaying the function of themember for holding the position of the pulling member and the functionof the above-described projected portion. The pulling member 6 can bepulled favorably by the member for holding the position of the pullingmember. It is preferable that the member for holding the position of thepulling member is disposed on an extension of a fixing portion 6 d, atthe proximal side thereof, where the pulling member 6 and the stentaccommodation cylindrical member 5 are fixed to each other. As themember for holding the position of the pulling member, it is possible touse members having the passage through which the pulling member 6 iscapable of penetrating. For example, it is possible to use a ring-shapedmember, a ring-shaped member having a cut-out, and a trough-shapedmember. It is preferable to use a plurality of the ring-shaped members.

As the tubular member 8, a tube having a lumen whose outer diameter islarger than that of the pulling member therein is used. The length ofthe tubular member 8 is favorably in the range of 10 to 180 mm and morefavorably in the range of 15 to 120 mm. The outer diameter of thetubular member is favorably in the range of 0.15 to 0.8 mm and morefavorably in the range of 0.2 to 0.5 mm. It is favorable that the innerdiameter of the tubular member is larger than the outer diameter of thepulling member by 0.05 to 0.2 mm.

It is preferable that the member for holding the position of the pullingmember is fixed to the outer surface of the distal-side tube 2. But themember for holding the position of the pulling member may be fixed tothe inner surface of the distal-side tube 2. Further the member forholding the position of the pulling member may be extended to the sidedistal from the distal end of the proximal-side tube 4. Furthermoreresin having low frictional property increasing lubricity may be appliedto the inner surface of the member for holding the position of thepulling member.

As shown in FIGS. 1, 2, and 4, the hub 12 is fixed to the proximalportion of the proximal-side tube 4. The hub 12 has a body 42 and avalve 43 accommodated inside the body 42 to hold the pulling member 6slidably and liquid-tightly. The hub 12 has a side port 45 branchingobliquely and rearward from a portion of the body 42 in the vicinity ofthe center thereof. The hub 12 has an inner tube locking mechanism forpreventing the movement of the pulling member 6. In this embodiment, theinner tube locking mechanism has the valve 43 liquid-tightly sandwichingthe proximal portion of the pulling member 6 by compression, anoperation member 44 for compressing the valve 43, and the body 42. Thelocking mechanism prevents the pulling member 6 from being pulledinadvertently. The valve 43 is mounted in a valve accommodation concaveportion provided at the proximal portion of the body 42. A pullingmember insertion passage is formed inside the valve 43. Even though thevalve 43 is not compressed, it holds the gap between it and the pullingmember liquid-tightly and prevents flow-out of blood. The valve of thisembodiment has an inner configuration (in other words, configuration ofinner tube insertion passage) formed by a partial overlapping of twoapproximately spheres in the axial direction of the hub 12. Thediameters of both ends of the valve 43 and the central portion thereofare reduced.

The operation member 44 has a cylindrical pressing portion 44 aprojected at the central portion of the hub 12 toward the distal side ofthe stent delivery device, a screwing portion 42 a formed on the outersurface of the rear end of the body 42, and a screwing portion 44 bcapable of screwing the screwing portion 42 a. The pulling memberinsertion passage is formed inside the pressing portion 44 a. As shownin FIG. 4, the distal-side portion of the pressing portion 44 apenetrates into the valve accommodation concave portion, thuscompressing the valve 43 owing to the movement of the operation membertoward the distal end of the hub 12.

In the locking mechanism, when screwing is progressed to move theoperation member 44 toward the distal side of the hub 12 by rotating theoperation member 44, the distal end of the valve-pressing portion 44 apresses the rear end of the valve 43. When the screwing is furtherprogressed by rotating the operation member 44, the valve 43 iscompressed axially. As the valve 43 is compressed, the valve contactsthe pulling member 6 closely, thus holding the pulling member 6 andfixing it thereto. The locking mechanism is released by rotating theoperation member 44 in an opposite direction.

It is preferable that the stent delivery device has the hub providedwith the above-described locking mechanism. But a hub 12 a may not havea locking mechanism as shown in FIG. 8. A hub body 42 a accommodates asealing member 43 a which allows the pulling member 6 to slidably movein a liquid-tight state. The sealing member 43 a is unmovable.

As materials for forming the hub body 42, 42 a and the operation member44, it is possible to use the following rigid or semi-rigid materials:synthetic resin including polycarbonate, polyolefins (for example,polyethylene, polypropylene, ethylene-propylene copolymer), styreneresin, for example, polystyrene, MS resin such as methacrylate-styrenecopolymer, MBS resin such as methacrylate-butylene-styrene copolymer,polyester; and metal such as stainless steel, aluminum, and aluminumalloy.

As the material for forming the valve 43 and the sealing member 43 a,the following elastic materials are used: rubbers including syntheticrubber such as urethane rubber, silicone rubber, butadiene rubber, andnatural rubber such as Latex rubber; synthetic resin elastomers such asolefin elastomers (for example polyethylene elastomer, polypropyleneelastomer), polyamide elastomer, styrene elastomers, (for example,styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer,styrene-ethylenebutylene-styrene copolymer), polyurethane, urethaneelastomers, fluororesin elastomers.

The method of using the stent delivery device 1 of the present inventionis described below with reference to the drawings.

In most cases, initially as shown in FIGS. 1 and 2, one end of the guidewire implanted in a human body is inserted into the opening 24 of thedistal-end member 25 to expose the guide wire (not shown) from theproximal-side opening 23. Thereafter the guide wire is inserted into aguide catheter (not shown) disposed in the human body. Thereafter thestent delivery device 1 is moved forward along the guide wire to disposea stent accommodation portion of the stent accommodation cylindricalmember 5 in a desired stenosed portion.

After the operation member 44 of the hub 12 of the proximal-side tube 4is operated to release the fixed state of the pulling member 6, theoperation member 44 of the pulling member 6 is pulled toward theproximal end of the stent delivery device. Thereby the stentaccommodation cylindrical member 5 axially moves to the proximal side ofthe stent delivery device. At this time, the rear end surface of thestent 3 contacts the distal end surface of the stent-locking portion 22of the distal-side tube 2 and is locked thereto. Thereby as the stentaccommodation cylindrical member 5 moves, the stent 3 is discharged fromthe opening at the distal end of the stent accommodation cylindricalmember 5. As shown in FIG. 9, owing to the discharge, the stent 3self-expands, expands the stenosed portion, and is implanted therein.

A stent delivery device 10 of another embodiment of the presentinvention is described below.

The stent delivery device 10 is the same as the stent delivery device 1except that the stent delivery device 10 does not have the intermediatetube and that the mode of the distal-side tube the former is differentfrom the mode of the distal-side tube of the latter. Other constructionof the former is the same as that of the latter. Thus the same parts ofthe former as those of the latter are denoted by the same referencenumerals as those of the latter, and description thereof is omittedherein.

The stent delivery device 10 of this embodiment has a distal-side tube 2a, the proximal-side tube 4, a stent accommodation cylindrical member 5a, the stent 3, and the pulling member 6.

As shown in FIGS. 10 and 11, as the stent accommodation cylindricalmember 5 a, a cylindrical member having almost the same diameter isused. A slit 59 as shown in FIG. 16 may be formed in the stentaccommodation cylindrical member 5 a. As shown in FIG. 16, a projectedportion 29 formed on the outer surface of the distal-side tube iscapable of advancing into the slit 59. In this embodiment, until thedistal end of the slit 59 contacts the projected portion 29, the stentaccommodation cylindrical member 5 a is movable toward the proximal sideof the stent delivery device. Thus the length of the slit 59 is setequally to or a little longer than the length in the range from theproximal end of the stent 3 accommodated in the stent accommodationcylindrical member 5 a to the distal end of the stent accommodationcylindrical member 5 a.

Materials similar to those for the stent accommodation cylindricalmember 5 are used to form the stent accommodation cylindrical member 5a. It is preferable to treat the outer surface of the stentaccommodation cylindrical member 5 a so that the outer surface thereofis lubricant. The treatment is made in the above-described manner. Tomake the lubricity of the stent 3 preferable, the above-describedmaterial may be applied or fixed to the inner surface of the stentaccommodation cylindrical member 5 a.

The stent 3 is accommodated at the distal portion of the stentaccommodation cylindrical member 5 a. The stent 3 is the same as thatdescribed above.

As shown in FIGS. 10 and 11, the distal-side tube 2 a is a tubular bodyhaving the guide wire lumen 21 penetrating through the distal-side tube2 a from its distal end to its proximal end. The distal-side tube 2 ahas a distal portion formed by a distal-end member 25 fixed to thedistal end thereof and has a distal-end opening 24. The distal portionformed by the distal-end member 25 may be formed integrally with thedistal-side tube 2 a. The proximal end of the distal-side tube 2 a isfixed to the distal end of the proximal-side tube. The guide wire lumen21 bends at the proximal portion thereof. The stent delivery device hasthe proximal-side opening 23 at the proximal portion (proximal end inthis embodiment) of the distal-side tube 2 a. As shown in FIG. 11, theproximal portion of the distal-side tube 2 a is curved. As shown inFIGS. 3 and 7, the proximal-side opening 23 is formed obliquely so thatit inclines toward the proximal side of the stent delivery device.Thereby it is easy to guide the guide wire.

The outer diameter of the distal-side tube 2 a is favorably in the rangeof 0.5 to 3.0 mm and more favorably in the range of 1.0 to 2.5 mm. Theinner diameter of the distal-side tube 2 a is favorably in the range of0.2 to 1.5 mm and more favorably in the range of 0.3 to 1.2 mm. Thelength of the distal-side tube 2 a is favorably in the range of 20 to600 mm and more favorably in the range of 30 to 350 mm.

As shown in FIG. 11, the distal-side tube 2 a has a stent-disposingsmall-diameter portion 26. The stent-locking portion for preventing thestent 3 to be implanted in the organism from moving to the proximal sidethereof is constructed of a proximal end 26 a of the stent-disposingsmall-diameter portion 26. The outer diameter of the proximal end 26 aof the stent-disposing small-diameter portion 26 is so set that thestent-locking portion 22 is capable of contacting the proximal end ofthe compressed stent 3. When the stent accommodation cylindrical member5 a moves to the proximal side of the stent delivery device, theproximal end 26 a keeps the position of the stent 3. Thereby the stent 3is discharged from the stent accommodation cylindrical member 5 a.

In this embodiment the outer diameter of the proximal-side tube 4 isalso set smaller than that of the portion, having the maximum diameter,which is disposed in the region of the stent delivery device 10 distalfrom the proximal-side tube 4. More specifically, in this embodiment,the stent accommodation cylindrical member 5 a has the maximum outerdiameter. The outer diameter of the proximal-side tube 4 is set smallerthan the outer diameter of the stent accommodation cylindrical member 5a. As shown in FIGS. 10 and 11, in this embodiment, the distal portionof the proximal-side tube 4 is fixed to the proximal portion of thedistal-side tube 2 a by shifting the axis of the proximal-side tube 4 ina direction away from the proximal-side opening 23 with respect to theaxis of the distal-side tube 2 a.

The distal-side tube 2 a extends from the vicinity of the fixing point 6d at which the pulling member 6 and the stent accommodation cylindricalmember 5 a are fixed to each other to the proximal side of the stentdelivery device. The distal-side tube 2 a has a passage 27 for thepulling member. In this embodiment the passage 27 for pulling member isformed of a concave portion extended axially on the outer surface of thedistal-side tube 2 a. The passage 27 for the pulling member may be alumen extended in penetration through the wall of the distal-side tube 2a.

In the stent delivery device 10 of this embodiment, by pulling theoperation member 53 of the pulling member 6 toward the proximal end ofthe stent delivery device, the stent accommodation cylindrical member 5a axially moves to the proximal side of the stent delivery device. Atthis time, the rear end surface of the stent 3 contacts the distal endsurface of the stent-locking portion 22 of the distal-side tube 2 a andis locked thereto. Thereby as the stent accommodation cylindrical member5 a moves, the stent 3 is discharged from the opening at the distal endof the stent accommodation cylindrical member 5 a. As shown in FIG. 12,the stent 3 self-expands and expands the stenosed portion and isimplanted therein.

In all the above-described embodiments, a plurality of (morespecifically, two) the pulling members may be provided.

A stent delivery device 20 shown in FIGS. 13 through 15 has two pullingmembers.

FIG. 13 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention. FIG. 14is an enlarged sectional view taken along a line C-C of FIG. 13. FIG. 15is an enlarged sectional view taken along a line D-D of FIG. 13.

The stent delivery device 20 is the same as the stent delivery device 1except that the stent delivery device 20 has two pulling members andthat there are some differences generated caused thereby. Otherconstruction of the former is the same as that of the latter. Thus thesame parts of the former as those of the latter are denoted by the samereference numerals as those of the latter, and description thereof isomitted herein. The above-described stent delivery device 10 may beprovided with two pulling members.

As shown in FIGS. 13 and 14, the stent accommodation cylindrical member5 of the stent delivery device 20 has two slits 52 a, 52 b extended fromthe proximal end of the stent accommodation cylindrical member 5 towardits distal end and disposed at positions opposed to each other. Incorrespondence to the positions of the slits 52 a, 52 b, the distal-sidetube 2 has two tubular members 8 a, 8 b formed at positions opposed toeach other.

Two pulling members 6 a, 6 b are fixed to the proximal portion of thestent accommodation cylindrical member 5 at positions opposed to eachother. As shown in FIGS. 13 through 15, the pulling member 6 a extendsinside the proximal-side tube 4 in penetration through a tubular member8 a and fixed to the operation member 53 at the proximal portionthereof. Similarly the pulling member 6 b extends inside theproximal-side tube 4 in penetration through a tubular member 8 b andfixed to the operation member 53 at the proximal portion of the stentaccommodation cylindrical member 5.

The distal portion of the stent delivery device may have a constructionas shown in FIGS. 17 and 18. FIG. 17 is an enlarged outlook view showinga distal portion of a stent delivery device of another embodiment of thepresent invention. FIG. 18 is an enlarged sectional view showing thedistal portion of the stent delivery device shown in FIG. 17.

The basic construction of the stent delivery device 30 is the same asthat of the stent delivery device 1 of the above-described embodiment.The stent delivery device 30 is different from the stent delivery device1 in that in the stent delivery device 1, the stent accommodationcylindrical member 5 slides on the inner side of the intermediate tube7, whereas in the stent delivery device 30, a stent accommodationcylindrical member 5 a slides on the outer side of an intermediate tube7 a. The stent accommodation cylindrical member 5 b has the samediameter over the whole length thereof. The intermediate tube 7 a hasalso the same diameter over the whole length thereof. The outer diameterof the intermediate tube 7 a is set a little smaller than the innerdiameter of the stent accommodation cylindrical member 5 b. Thus in thestent delivery device 30, the stent accommodation cylindrical member 5 bhas the largest diameter.

As described above, the distal portion of the intermediate tube 7 apenetrates into the stent accommodation cylindrical member 5 b from itsproximal end. As shown in FIG. 18, the pulling wire 6 is fixed to theinner side of the stent accommodation cylindrical member 5 at a fixingpoint 69 provided at the vicinity of the stent. The proximal portion ofthe distal-side tube 2 and the distal portion of the proximal-side tube4 are fixed to the proximal portion of the intermediate tube 7 a.

Similarly to the stent delivery device 1, the stent accommodationcylindrical member 5 b is not bonded to the intermediate tube 7 a, butis movable. Although the stent accommodation cylindrical member 5 b ismoved to the proximal side of the stent delivery device by pulling thepulling wire 6, the stent 3 is locked to the stent-locking portion 22.Thus the stent 3 is discharged from the stent accommodation cylindricalmember 5 b and self-expands. Even though the entire tube is made of asoft material, this mode allows the stent to be expanded safely withoutbeing bent in a curved blood vessel or the like, because the pullingwire is disposed inside the tube.

The distal portion of the stent delivery device may have a constructionas shown in FIGS. 19 through 22. The basic construction of the stentdelivery device 40 is the same as that of the above-described stentdelivery device 1. FIG. 19 is an enlarged outlook view showing a distalportion of a stent delivery device of another embodiment of the presentinvention. FIG. 20 is a sectional view taken along a line E-E of FIG.19. FIG. 21 is an enlarged sectional view taken along a line F-F of FIG.19. FIG. 22 is an enlarged sectional view taken along a line G-G of FIG.19.

The stent delivery device 40 is different from the stent delivery device1 in that in the stent delivery device 1, the stent accommodationcylindrical member 5 slides on the inner side of the intermediate tube7, whereas in the stent delivery device 40, a stent accommodationcylindrical member 5 b slides on the outer side of an intermediate tube47. The stent accommodation cylindrical member 5 b has the same diameterover the whole length thereof. The intermediate tube 7 a has also thesame diameter over the whole length thereof except its proximal portion.The outer diameter of the intermediate tube 47 is set a little smallerthan the inner diameter of the stent accommodation cylindrical member 5b. Thus in the stent delivery device 40, the stent accommodationcylindrical member 5 b has the largest diameter.

As described above, the distal portion of the intermediate tube 47penetrates into the stent accommodation cylindrical member 5 b from itsproximal end. As shown in FIGS. 19 and 20, the stent delivery device 40has a plurality of (two) pulling wires 6 a, 6 b. The pulling members 6a, 6 b are fixed to the inner side of the stent accommodationcylindrical member 5 b at fixing points 69 a, 69 b respectively. Thepulling wires 6 a, 6 b are disposed at positions substantially opposedto each other. The fixing points 69 a, 69 b are disposed at positionssubstantially opposed to each other.

As shown in FIG. 21, an intermediate tube 47 has axially extended bulgedportions 47 a, 47 b for accommodating the pulling wire. The bulgedportions 47 a, 47 b are formed at positions opposed to each other.Except the bulged portions 47 a, 47 b, the intermediate tube 47 isproximate to the distal-side tube 2. This construction prevents thepulling wire from moving on the outer surface of the distal-side tube 2and allows the pulling wire to be pulled favorably.

As shown in FIGS. 20 and 22, the diameter of the intermediate tube 47 isdecreased at its proximal side. The axially extended bulged portions 47a and 47 b for accommodating the pulling wire, which are formed atpositions opposed to each other are proximate to the pulling wires 6 aand 6 b respectively. Except the bulged portions 47 a, 47 b, theintermediate tube 47 is proximate to the distal-side tube 2. As shown inFIG. 20, the diameter-decreased proximal side of the intermediate tube47 penetrates into the distal portion of a connection tube 48 and isfixed thereto. The proximal portion of the distal-side tube 2 and thedistal portion of the proximal-side tube 4 are fixed to the proximalportion of the connection tube 48.

Similarly to the stent delivery device 1, the stent accommodationcylindrical member 5 b is not bonded to the intermediate tube 47 andmovable. Although the stent accommodation cylindrical member 5 b ismoved to the proximal side of the stent delivery device by pulling thepulling members 69 a, 69 b, the stent 3 is locked to the stent-lockingportion 22. Thus the stent 3 is discharged from the stent accommodationcylindrical member 5 b and self-expands. Even though the entire tube ismade of a soft material, this mode allows the stent to be expandedsafely without being bent in a blood vessel or the like, because thepulling wire is disposed inside the tube.

In the stent delivery device of the present invention, it is possible toprevent the movement of the stent toward the distal end thereof and easyto insert the stent delivery device to a desired portion of an organ,provided that the distal-side tube of the stent delivery device has aprojected portion, for preventing the movement of the stent, which isprovided at the side distal from the distal end of the stent andprovided that the distal side of the above-described projected portionis gradually decreased in its diameter toward the distal end thereof.

In the stent delivery device of the present invention, it is possible topull the pulling member favorably, provided that the stent deliverydevice has a member, for maintaining the position of the pulling member,which is disposed on the outer surface of the distal-side tube and has apassage through which the pulling member is capable of penetrating.

In the stent delivery device of the present invention, it is possible tomove the stent accommodation cylindrical member to move favorably towardthe proximal side of the stent delivery device, provided that aprojected portion is provided on an outer surface of the distal-sidetube and that the stent accommodation cylindrical member has a slitwhich extends from a proximal end thereof toward a distal side thereofand into which the projected portion is capable of moving.

In the stent delivery device of the present invention, it is possible toprevent the stent accommodation cylindrical member from movingexcessively, provided that the stent delivery device has a portion forrestricting a movement distance of the stent accommodation cylindricalmember toward the proximal side of the stent delivery device.

EXAMPLE

The stent delivery device shown in FIGS. 1 through 7 was formed. Thestent delivery device of this embodiment was formed on condition that aguide wire having a diameter of 0.035 inches. That is, the stentdelivery device is of a so-called rapid exchange type. As thedistal-side tube, a tube made of polyether ether ketone was used. Theouter diameter and inner diameter of the distal-side tube were 1.23 mmand 0.95 mm respectively. As the stent-locking portion, a stainlesssteel ring was caulked to the outer surface of the distal-side tube. Asthe distal-end member, a polyester elastomer formed by injection moldingwas used. The stent was prepared by cutting a piece from a tube made ofnickel titanium. As the stent accommodation cylindrical member, apolyimide tube was used. The outer diameter and inner diameter of thestent accommodation cylindrical member were 2.06 mm and 1.8 mmrespectively. The outer diameter and inner diameter of thesmall-diameter portion were 1.60 mm and 1.36 mm respectively. As theintermediate tube, a tube made of polyimide tube was used. The outerdiameter and inner diameter of the intermediate tube were 2.06 mm and1.80 mm respectively. As the proximal-side tube, a tube made ofpolyether ether ketone was used. The outer diameter and inner diameterof the proximal-side tube were 1.1.6 mm and 0.85 mm respectively. As thepulling member, a stainless steel single wire was used. The outerdiameter of the pulling member at its distal portion was 0.3 mm (length:15 cm). The outer diameter at the proximal side thereof was 0.52 mm.

The stent delivery device of this embodiment was approached to asimulated blood vessel of an iliac arteria by using an introducer toexpand the stent. The result was that the stent did not move.

A stent delivery device of another embodiment of the present inventionis described below.

FIG. 24 is a partially schematic front view showing a stent deliverydevice of an embodiment of the present invention. FIG. 25 is an enlargedoutlook view showing the neighborhood of a distal portion of the stentdelivery device shown in FIG. 24. FIG. 26 is an enlarged sectional viewshowing the neighborhood of the distal portion of the stent deliverydevice shown in FIG. 24. FIG. 27 is an enlarged outlook view showing theneighborhood of an operation portion of the stent delivery device shownin FIG. 24. FIG. 28 is an enlarged sectional view taken along a line H-Hof FIG. 25. FIG. 29 is an enlarged sectional view taken along a line I-Iof FIG. 25.

The outlook view showing the stent accommodation cylindrical member foruse in the stent delivery device of this embodiment is similar to thatshown in FIG. 5. Thus FIG. 5 is referred to.

A stent delivery device 50 of the present invention includes adistal-side tube 2 having a guide wire lumen 21; a proximal-side tube 4whose distal portion is fixed to a proximal portion of the distal-sidetube 2; a stent accommodation cylindrical member 5 which encloses adistal side of the distal-side tube 2 and is slidable toward a proximalend of the distal-side tube 2; a stent 3 accommodated in the stentaccommodation cylindrical member 5; and a pulling member 6 which extendsinside the proximal-side tube 4, with one end portion thereof fixed tothe stent accommodation cylindrical member 5 and is pulled toward theproximal side of the proximal-side tube 4 to move the stentaccommodation cylindrical member 5 toward a proximal side of the stentdelivery device 1.

The distal-side tube 2 has a proximal-side opening 23 which is open atthe proximal side of the distal-side tube 2 and communicates with theguide wire lumen 21; and a stent-locking portion 22 which is disposed atthe distal side of the distal-side tube 2 and contacts a proximal end ofthe stent 3 accommodated inside the stent accommodation cylindricalmember 5, thus preventing the stent 3 from moving to the proximal sideof the stent delivery device. The stent 3 is formed approximatelycylindrically and accommodated in the stent accommodation cylindricalmember 5, with the stent 3 being compressed in an axial directionthereof. The stent 3 expands outward and returns to a configurationbefore the stent is compressed, when the stent is implanted in anorganism.

At the proximal portion of the proximal-side tube 4, the stent deliverydevice 50 includes an operation portion 9 having a pulling wire windingmechanism for winding the pulling wire 6 and moving the stentaccommodation cylindrical member 5 toward the proximal side of the stentdelivery device.

According to the stent delivery device of the present invention using aself-expandable stent the opening at the proximal side thereof isdisposed not at the proximal end thereof, but at the proximal side ofthe distal-side tube. Therefore in a stent-implanting operation, it iseasy to perform an operation of exchanging the stent delivery devicewith a stent delivery device of other type. By pulling the pulling wireto the proximal side of the stent delivery device, the stent can bedischarged from the stent accommodation cylindrical member. Thus theposition movement amount of the stent is very small in an operation ofdischarging the stent from the stent accommodation cylindrical member.

The operation portion 9 has a housing 91 (91 a, 91 b). It is preferablethat the pulling wire winding mechanism has a rotational roller 61 foroperational use (hereinafter referred to as merely rotational roller 61)having a portion exposed from the housing 91 and that by rotating therotational roller 61, the pulling wire 6 is wound on the rotationalroller 61 at its proximal side. This construction allows the operationportion 9 to be compact and an operation of rotating the rotationalroller to be accomplished, with the housing 91 being held with a hand.Thus it is possible to perform an operation of discharging the stentfrom the stent delivery device with one hand.

It is preferable that in the stent delivery device 50, the outerdiameter of the proximal-side tube 4 is set smaller than that of theportion, having the maximum diameter, which is disposed in the region ofthe stent delivery device 50 distal from the proximal-side tube 4. Inthis construction, even in a state in which the guide wire is extendedalong the side surface of the proximal-side tube from the opening at theproximal side of the stent delivery device to the proximal side of thestent delivery device, the outer diameter of the proximal-side tube isset almost equally to that of the portion, having the maximum diameter,which is disposed in the region of the stent delivery device distal fromthe proximal-side tube. Thereby the stent can be inserted into a narrowblood vessel.

The stent delivery device 50 of this embodiment has the distal-side tube2, the proximal-side tube 4, the stent accommodation cylindrical member5, the stent 3, the pulling wire 6, and an operation portion 9 having amechanism for winding the pulling wire 6.

The stent delivery device 50 of this embodiment has the intermediatetube 7 that encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 and isfixed at the proximal portion thereof to the proximal portion of thedistal-side tube 2 and the distal portion of the proximal-side tube 4.In the stent delivery device 50 of this embodiment, the intermediatetube 7 encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 withoutpreventing the stent accommodation cylindrical member 5 from movingtoward the proximal side of the stent delivery device 50. One endportion of the pulling wire 6 is fixed to the stent accommodationcylindrical member 5 inside the intermediate tube 7. The pulling wire 6passes between the intermediate tube 7 and the distal-side tube 2 andextends into the proximal-side tube 4. This construction is preferablein that the pulling wire is not exposed.

The stent accommodation cylindrical member 5 is the same as that of thestent delivery device 1 of the above-described embodiment. As the stent3, it is possible to use the self-expandable stent having anyconstructions. For example, it is possible to preferably use the stent 3of the stent delivery device 1 of the above-described embodiment. Asshown in FIGS. 25 through 29, the distal-side tube 2 is a tubular bodyhaving the guide wire lumen 21 penetrating through the distal-side tube2 from its distal end to its proximal end. The distal-side tube 2 has adistal portion formed by a distal-end member 25 fixed to the distal endthereof and has a distal-end opening 24. The distal-side tube 2 is thesame as that of the stent delivery device 1 of the above-describedembodiment. The distal-end member 25 is also the same as that of thestent delivery device 1 of the above-described embodiment. As shown inFIGS. 25 and 26, the distal-side tube 2 has the stent-locking portion 22for preventing the stent 3 from moving toward the proximal side of thestent delivery device 50. The stent-locking portion 22 is the same asthat of the stent delivery device 1 of the above-described embodiment.

As shown in FIGS. 24 through 29, the proximal-side tube 4 is a tubularbody extending from its distal end to its proximal end. Theproximal-side tube 4 has a hub 12 fixed to its proximal end. The distalportion of the proximal-side tube is joined with the proximal portion ofthe distal-side tube 2. The proximal-side tube 4 has therein a lumen 41through which the pulling wire 6 can be inserted.

The proximal-side tube 4 is the same as that of the stent deliverydevice 1 of the above-described embodiment. In the stent delivery device50 of this embodiment similarly to the stent delivery device 1 of theabove-described embodiment, the outer diameter of the proximal-side tube4 is set smaller than that of the portion, having a maximum diameter,which is disposed in the region of the stent delivery device 50 distalfrom the proximal-side tube 4. More specifically, in this embodiment,the outer diameter of the proximal-side tube 4 is set smaller than themaximum outer diameter of the portion where the distal-side tube 2 andthe proximal-side tube 4 are fixed to each other.

Similarly to the stent delivery device 1 of the above-describedembodiment, the stent delivery device 50 of this embodiment has theintermediate tube 7 which encloses the proximal side of the distal-sidetube 2 and the proximal side of the stent accommodation cylindricalmember 5 and is fixed at the proximal portion thereof to the proximalportion of the distal-side tube 2 and the distal portion of theproximal-side tube 4. In the stent delivery device 50 of thisembodiment, the intermediate tube 7 encloses the proximal side of thedistal-side tube 2 and the proximal side of the stent accommodationcylindrical member 5 without preventing the stent accommodationcylindrical member 5 from moving toward the proximal side of the stentdelivery device 50. One end portion of the pulling wire 6 is fixed tothe stent accommodation cylindrical member 5 inside the intermediatetube 7. The pulling wire 6 passes between the intermediate tube 7 andthe distal-side tube 2 and extends into the proximal-side tube 4.

The proximal portion of the distal-side tube 2 extends inside theintermediate tube 7 and is exposed from the proximal end of theintermediate tube 7. The distal portion of the proximal-side tube 4penetrates into the proximal portion of the intermediate tube 7. Thedistal-side tube 2, the proximal-side tube 4, and the intermediate tube7 are liquid-tightly fixed to the proximal portion of the intermediatetube 7. The lumen 41 inside the proximal-side tube 4 communicates withthe inside of the intermediate tube 7. As shown in FIGS. 25 and 26, thedistal portion of the intermediate tube 7 is decreased in its diameteror curved. It is preferable that the distal end of the intermediate tube7 liquid-tightly contacts the outer surface of the stent accommodationcylindrical member 5 without preventing the movement of the stentaccommodation cylindrical member 5. But the distal end of theintermediate tube 7 does not necessarily have to contact the outersurface of the stent accommodation cylindrical member 5. Theintermediate tube is the same as that of the stent delivery device 1 ofthe above-described embodiment.

The stent delivery device 50 has the pulling wire 6 extending inside theproximal-side tube 4, with one end portion thereof fixed to the stentaccommodation cylindrical member 5. The pulling wire 6 is pulled towardthe proximal side of the proximal-side tube 4 to move the stentaccommodation cylindrical member 5 to the proximal side of the stentdelivery device.

In the stent delivery device 50 of this embodiment the pulling member 6is constructed of a pulling wire. As shown in FIGS. 24, 25, and 27, thepulling wire 6 penetrates through the proximal-side tube 4 and extendsto the outside from the proximal end of the proximal-side tube 4. Thepulling wire 6 is the same as that of the stent delivery device 1 of theabove-described embodiment.

The stent delivery device 50 of this embodiment has the projectedportion (tubular member) 8 provided on the outer surface of thedistal-side tube 2 at its proximal side. The projected portion 8(tubular member) is capable of moving inside the slit 52 of the stentaccommodation cylindrical member 5. The projected portion 8 (tubularmember) is the same as that of the stent delivery device 1 of theabove-described embodiment.

The stent delivery device 50 of this embodiment has a member for holdingthe position of the pulling wire. This member is disposed on the outersurface of the distal-side tube 2 and has a passage through which thepulling wire 6 is capable of penetrating. The stent delivery device ofthis embodiment has a tubular member 8 displaying the function of themember for holding the position of the pulling wire and the function ofthe above-described projected portion. The pulling wire 6 can be pulledfavorably by the member for holding the position of the pulling wire. Itis preferable that the member for holding the position of the pullingwire is disposed on an extension of a fixing portion 6 d, at theproximal side thereof, where the pulling wire 6 and the stentaccommodation cylindrical member 5 are fixed to each other. As themember for holding the position of the pulling wire, it is possible touse members having the passage through which the pulling wire 6 iscapable of penetrating. For example, it is possible to use a ring-shapedmember, a ring-shaped member having a cut-out, and a trough-shapedmember. It is preferable to use a plurality of the ring-shaped members.

As the tubular member 8, a tube having a lumen whose outer diameter islarger than that of the pulling member therein is used. The length ofthe tubular member 8 is favorably in the range of 10 to 180 mm and morefavorably in the range of 15 to 120 mm. The outer diameter of thetubular member is favorably in the range of 0.15 to 0.8 mm and morefavorably in the range of 0.2 to 0.5 mm. It is favorable that the innerdiameter of the tubular member is larger than the outer diameter of thepulling member by 0.05 to 0.2 mm.

It is preferable that the member for holding the position of the pullingmember is fixed to the outer surface of the distal-side tube 2. But themember for holding the position of the pulling member may be fixed tothe inner surface of the distal-side tube 2. Further the member forholding the position of the pulling member may be extended to the sidedistal from the distal end of the proximal-side tube 4. Furthermoreresin having low frictional property which increases lubricity may beapplied to the inner surface of the member for holding the position ofthe pulling member.

As shown in FIGS. 24, 27, 30 through 32, the stent delivery device 50 ofthe present invention has the operation portion 9 fixed to at theproximal end of the proximal-side tube 4, namely, to a hub 42 providedat the proximal end of the proximal-side tube 4.

The operation portion 9 of the stent delivery device 50 has a pullingwire winding mechanism, a locking mechanism for releasably locking arotation of the pulling wire winding mechanism, and a reverse rotationprevention mechanism for preventing the rotation of the pulling wirewinding mechanism in a direction opposite to a pulling wire windingdirection.

The operation portion 9 has a housing 91 composed of a body 91 a and acovering member 91 b sealing an open portion of the body 91 a. Aconnector 93 which is connected with a hub 42 is fixed to the distalportion of the housing 91. The housing 91 has a pulling wire passage 97extended from the distal end of the distal portion thereof to the insidethereof. The connector 93 is fixed to the distal portion of the housing91 by means of a fixing member 96 in such a way that a passage insidethe connector 93 communicates with the pulling wire passage 97.

As shown in FIGS. 27, 30, and 33, the connector 93 includes a hollowbody 93 a, a connection port 93 b extended from the body 93 a, a sideport 93 c, and a sealing member 93 d holding the pulling wire 6 slidablyand liquid-tightly. The connection port 93 b is mounted at the proximalportion of the hub 42 of the proximal-side tube 4.

As materials for forming the housing of the operation portion, theconnector 93, and the hub 42, it is possible to use the following rigidor semi-rigid materials: synthetic resin including polycarbonate,polyolefins (for example, polyethylene, polypropylene,ethylene-propylene copolymer), styrene resin, for example, polystyrene,MS resin such as methacrylate-styrene copolymer, MBS resin such asmethacrylate-butylene-styrene copolymer, polyester; and metal such asstainless steel, aluminum, and aluminum alloy.

The housing 91 is so provided as to enclose a pulling wire passage 97.The housing 91 projects from the proximal ends of the pulling wirepassage 97 and has a wire protection tube 95 extending inside thehousing. The wire protection tube 95 is made of a flexible material oran elastic material.

As the material for forming the sealing member 93 and the wireprotection tube 95, the following elastic materials are used: rubbersincluding synthetic rubber such as urethane rubber, silicone rubber,butadiene rubber, and natural rubber such as Latex rubber; syntheticresin elastomers such as olefin elastomers (for example polyethyleneelastomer, polypropylene elastomer), polyamide elastomer, styreneelastomers, (for example, styrene-butadiene-styrene copolymer,styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrenecopolymers polyurethane, urethane elastomers, fluororesin elastomers.

As shown in FIG. 30, the body 91 a of the housing includes an openportion 98 for partly projecting the rotational roller 61, a locking rib99 engaging a projected portion of a gear portion 62 (see FIG. 33)provided on the roller 61, and a bearing portion 94 b accommodating oneend 64 b of the rotating shaft of the roller 61. The covering member 91b has a bearing portion 94 a accommodating the other end 64 a of therotating shaft of the roller 61. The locking rib 99 is so configuredthat it is capable of penetrating into the gap between adjacentprojected portions formed on the gear portion 62 of the roller 61. Asshown in FIGS. 31 and 32, the bearing portions 94 a and 94 b accommodatethe other end 64 a and the one end 64 b of the rotating shaft of theroller 61 respectively and are oblongly extended in a direction in whichthey recede from the above-described locking rib 99. The bearingportions 94 a and 94 b are not limited to an oblong configuration, butmay have configurations which allow them to move a distance in whichthey disengage from the locking rib. For example, the bearing portions94 a and 94 b may be rectangular, elliptic, and gourd-shaped like anoperation portion 100 of the embodiment that will be described later. Asshown in FIGS. 31 and 32, the bearing portions 94 a and 94 b of thisembodiment are formed in parallel with the rotational shaft of theroller 61 and extend downward (vertical direction of open portion 98).The bearing portions 94 a and 94 b have a length allowing the roller 61to move a distance longer than the height of the locking rib 99.

The pulling wire winding mechanism is constructed of the roller 61 and awinding shaft portion 63 which is rotated by the rotation of the roller61. The proximal portion of the pulling wire 6 is held by the windingshaft portion 63 or secured thereto. More specifically, as shown in FIG.32, an anchoring portion 65 larger than the wire 6 is provided at theproximal portion of the pulling wire 6. A slit 63 a capable ofaccommodating the pulling wire 6 is formed in the winding shaft portion63. The slit 63 a of the winding shaft portion 63 accommodates theproximal portion of the pulling wire 6, with the anchoring portion 65disposed outward from the proximal end of the slit 63 a. Thereby whenthe winding shaft portion 63 having the above-described constructionrotates, the wire 6 is wound on the outer surface thereof, as shown inFIG. 35. The method of holding the pulling wire 6 on the winding shaftportion 63 or securing the pulling wire 6 thereto is not limited to theabove-described method, but any methods can be used. For example, theproximal end of the pulling wire 6 or the proximal portion thereof maybe directly secured to the winding shaft.

It is preferable that the proximal portion of the pulling wire 6 to bewound on the winding shaft portion 63 is soft to allow the pulling wire6 to be wound easily. To make the proximal portion of the pulling wire 6flexible, it is possible to adopt a method of forming the proximalportion of the pulling wire 6 of a flexible material and a method ofdecreasing the diameter of the proximal portion of the pulling wire 6.

In this embodiment, the winding shaft-portion 63 is formed integrallywith the rotational roller 61 to make the winding shaft portion 63 andthe rotational roller 61 coaxial with each other. Thus by rotating therotational roller 61, the winding shaft portion 63 rotatessimultaneously therewith. It is preferable that the winding amount ofthe pulling wire is smaller than the amount of an operation required torotate the rotational roller. By doing so, the pulling wire can be woundslowly and the stent accommodation cylindrical member 5 is allowed tomove toward the proximal side of the stent delivery device slowly andfavorably. In this embodiment because the outer diameter of the windingshaft portion is set smaller than that of the rotational roller, thewinding amount of the pulling wire is allowed to be smaller than theamount of the operation required rotating the rotational roller.

The outer diameter of the winding shaft portion 63 is favorably in therange of 1 to 60 mm and more favorably in the range of 3 to 30 mm. Theouter diameter of the rotational roller is favorably 1 to 20 times andmore favorably 1 to 10 times larger than that of the p winding shaftportion. More specifically, the outer diameter of the rotational rolleris favorably in the range of 10 to 60 mm and more favorably in the rangeof 15 to 50 mm.

The rotational roller and the winding shaft portion do not necessarilyhave to be formed integrally, but the winding shaft portion may beconstructed of a separate member which follows the rotation of therotational roller. As the transmission system of the rotational roller,it is possible to use a gear type, a belt type, and the like. It ispreferable that surfaces of parts which have a possibility of contactwith the surface of the rotational roller 61 in operating the rotationalroller 61 is not slippery. For example, it is preferable to treatsurfaces of parts which have a possibility of contact with the surfaceof the rotational roller 61 in operating the rotational roller 61 byknurling treatment emboss treatment application of a high-frictionalmaterial, and the like.

The operation portion 9 of this embodiment has the locking mechanism forreleasably locking the rotation of the pulling wire winding mechanismand the reverse rotation prevention mechanism for preventing therotation of the pulling-wire winding mechanism in the direction oppositeto the pulling wire winding direction.

As shown in FIGS. 27, 30 through 33, the rotational roller 61 has thegear portion 62 which is coaxial therewith and rotates togethertherewith. The rotational roller 61 has a portion partly exposed fromthe open portion 98. The exposed portion serves as the operationportion. The roller 61 has other end 64 a provided on one side surfaceof the rotating shaft thereof and one end 64 b provided on the otherside surface (side surface of winding shaft) thereof. An urging means 92for urging the rotational roller 61 toward the open portion 98 of thehousing 91 is provided inside the housing 91. More specifically, anurging member 92 b of the urging means 92 urges the roller 61. The body91 a of the housing accommodates the locking rib 99 capable ofpenetrating into the gap between adjacent projected portions formed onthe gear portion 62 of the roller 61. Therefore the rotating roller 61has a state shown in FIG. 33, when the rotating roller 61 is urged bythe urging member 92 b. Thus the locking rib 99 engages the projectedportion of the gear portion 62, which prevents the rotating roller 61from rotating. When the rotating roller 61 is pressed in the directionin which it moves away from the locking rib 99, namely, in a directionshown with the arrow of FIG. 34, the one end 64 b and other end 64 a ofthe rotating shaft of the roller 61 move inside the bearing portions 94b and 94 a respectively provided in the housing 91. Thereby therotational roller 61 has a state shown in FIG. 34. In this state, thelocking rib 99 is in disengagement from the projected portions of thegear portion 62 and thus rotatable. Thus the operation portion 9 of thisembodiment prevents the rotation of the rotational roller 61 when it isnot pressed and has the locking mechanism for releasably locking therotation of the pulling wire winding mechanism.

The operation portion of this embodiment has the reverse rotationprevention mechanism composed of the urging means 92 having the urgingmember 92 b and the above-described gear portion 62. The reverserotation prevention mechanism prevents the rotation of the pulling wirewinding mechanism in the direction opposite to the pulling wire windingdirection. The urging means 92 has the urging member 92 b and the fixingmember 92 a for fixing the urging member 92 b to the housing 91. As theurging member 92 b, a leaf spring is used. The leaf spring-extends fromthe fixing member 92 a to a lower portion of the gear portion 62 throughthe rear (direction opposite to distal portion of operation portion) ofthe gear portion 62 in such a way that the distal end of the leaf springengages the projected portions disposed at the lower portion of the gearportion 62. Because the leaf spring is pressed against the gear portion62, with the leaf spring in contact therewith, as described above, theroller 62 is urged toward the open portion 98 of the housing. The roller61 is pressed as described above and has a state shown in FIG. 33 inwhich the roller 61 is rotatable. As shown in FIG. 35, the roller 61 isrotatable in the direction (pulling wire-winding direction) shown withthe arrow of FIG. 35. If an operation of rotating the roller 61 in theopposite direction is performed, the projected portion of the gearportion 62 and the distal end of the urging member 92 b engage eachother. Thereby the rotation of the roller 61 is prevented. Thereby thereverse rotation prevention mechanism prevents the rotation of thepulling wire winding mechanism in the direction opposite to the pullingwire winding direction. As the material for the leaf spring serving asthe urging member, any materials capable of displaying elasticity can beused. For example, it is possible to use metal (steel for spring) andsynthetic resin.

The outer diameter of the gear portion 62 is favorably in the range of10 to 60 mm and more favorably in the range of 15 to 50 mm. The numberof cogs thereof is favorably in the range of 4 to 200 mm and morefavorably in the range of 4 to 70.

The operation portion may have a construction as shown in FIGS. 41through 43.

FIG. 41 is an enlarged outlook view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention. FIG. 42 is an enlarged sectional view showing theneighborhood of the operation portion of the stent delivery device shownin FIG. 41. FIG. 43 is an explanatory view for explaining an internalconstruction of the neighborhood of an operation portion of the stentdelivery device shown in FIG. 41.

The basic construction of an operation portion 100 of the stent deliverydevice of this embodiment is the same as that of the above-describedoperation portion 9. The operation portion 100 is different from theoperation portion 9 in the configuration of the housing 101, and theposition of the winding shaft portion 63 and that of the gear portion 62for the rotational roller 61. In addition, the operation portion 100 hasa collar member 102 and a connector 93 has a wire protection tube 93 e.

As shown in FIGS. 41 and 42, the operation portion 100 has a housing101. The proximal side of the housing 101 is bent and rounded. Thisconfiguration allows the housing 101 to be held easily and the roller tobe operated easily. The housing 101 has a connector-mounting portion atits distal portion. The connector-mounting portion is formed as aconcave portion on which the proximal portion of the connector 93 can bemounted.

As shown in FIG. 42, the connector 93 includes a hollow body 93 a, aconnection port 93 b extended from the body 93 a, a side port 93 cextended therefrom, a sealing member 93 d holding the pulling wire 6slidably and liquid-tightly, and the wire protection tube 93 e. The wireprotection tube 93 e extends from the body 93 a and is projected intothe housing 101.

As the material for forming the housing 101 of the operation portion andthe connector 93, the following elastic materials are used: rubbersincluding synthetic rubber such as urethane rubber, silicone rubber,butadiene rubber, and natural rubber such as Latex rubber; syntheticresin elastomers such as olefin elastomers (for example polyethyleneelastomer, polypropylene elastomer), polyamide elastomer, styreneelastomers, (for example, styrene-butadiene-styrene copolymer,styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrenecopolymer), polyurethane, urethane elastomers, fluororesin elastomers.

As shown in FIGS. 41 and 42, the housing 101 includes an open portionfor partly projecting the rotational roller 61, a locking rib 99engaging projected portions of a gear portion 62 (see FIG. 42) providedon the roller 61, a bearing portion 94 b accommodating one end 64 b ofthe rotating shaft of the roller 61, and a bearing portion 94 aaccommodating the other end 64 a of the rotating shaft of the roller 61.The locking rib 99 is so configured that it is capable of penetratinginto the gap between adjacent projected portions formed on the gearportion 62 of the roller 61. As shown in FIGS. 41 and 42, the bearingportions 94 a and 94 b accommodate the one end 64 b and the other end 64a of the rotating shaft of the roller 61 respectively and have the shapeof a gourd extended in a direction in which they recede from theabove-described locking rib 99. The bearing portions 94 a and 94 b arenot limited to the shape of the gourd, but may have configurations whichallow them to move a distance in which they are capable of disengagingfrom the locking rib. For example, the bearing portions 94 a and 94 bmay be rectangular, elliptic, and gourd-shaped. In the operation portion100 of the embodiment, the bearing portions 94 a and 94 b are gourdlike,as shown in FIGS. 41 and 42. Therefore the rotational roller 61 ispressed to allow the ends 64 b, 64 a of the rotating shaft of the roller61 accommodated in a space formed at one side of the bearing portions 94a, 94 b to ride across opposed rib portions formed on the inner sidesurface of the central portion of the bearing portions 94 a, 94 b.Thereby the ends 64 b, 64 a of the rotating shaft of the roller 61 areaccommodated in a space formed at the other side of the bearing portions94 a, 94 b. In this state, the roller 61 is pressed by the urgingmember. Thereby the ends 64 b, 64 a of the rotating shaft of the roller61 contact opposed ribs formed on the inner side surface of the centralportion of the bearing portions 94 a, 94 b and thus do not move to thespace formed at the one side of the bearing portions 94 a, 94 b.Therefore the roller 61 keeps a rotatable state.

In this embodiment, the operation portion 100 has the collar member 102.The collar member 102 accommodates the winding shaft portion 63 and hasa collar portion 104 forming an annular space between it and the windingshaft portion 63. The collar portion 104 prevents the pulling wire woundaround the winding shaft portion 63 from becoming loose. The collarmember 102 has a function of guiding the rotational roller in itsmovement and suppressing shaking of the rotational roller, when therotational roller is pressed. The shaft of the collar member 102 issupported with a pin 103. Thus as shown in FIGS. 41 and 42, the bearingportions 94 a, 94 b are formed in the shape of a gentle circular arcabout the pin 103. The bearing portions 94 a and 94 b have the lengthallowing the roller 61 to move a distance longer than the height of thelocking rib 99. As shown in FIG. 43, the collar member 102 has a passage105 which reaches the space inside the collar portion 104 from the sidesurface thereof. The pulling wire 6 penetrates through the passage 105and is fixed to the winding shaft portion 63.

The pulling wire winding mechanism is constructed of the roller 61 andthe winding shaft portion 63 which is rotated by the rotation of theroller 61. The proximal portion of the pulling wire 6 is held by thewinding shaft portion 63 or secured thereto. More specifically, as shownin FIG. 42, an anchoring portion 65 larger than the wire 6 is providedat the proximal portion of the pulling wire 6. A slit 63 a capable ofaccommodating the pulling wire 6 is formed in the winding shaft portion63. The slit 63 a of the winding shaft portion 63 accommodates theproximal portion of the pulling wire 6, with the anchoring portion 65disposed outward from the slit 63 a. Thereby when the winding shaftportion 63 having the above-described construction rotates, the wire 6is wound on the outer surface thereof. The method of holding theproximal portion of the pulling wire 6 on the winding shaft portion 63or securing the pulling wire 6 thereto is not limited to theabove-described method, but any methods can be used. For example, theproximal end of the pulling wire 6 or the proximal portion thereof maybe directly secured to the winding shaft.

It is preferable that the proximal portion of the pulling wire 6 to bewound on the winding shaft portion 63 is soft to allow the pulling wire6 to be wound easily. To make the proximal portion of the pulling wire 6flexible, it is possible to adopt a method of making the proximalportion of the pulling wire 6 of a flexible material and a method ofdecreasing the diameter of the proximal portion of the pulling wire 6.

In this embodiment the winding shaft portion 63 is formed integrallywith the rotational roller 61 to make the winding shaft portion 63 andthe rotational roller 61 coaxial with each other. As shown in FIG. 43,the winding shaft portion 63 is provided on one side surface of therotational roller 61. Thus by rotating the rotational roller 61, thewinding shaft portion 63 rotates simultaneously therewith. It ispreferable that the winding amount of the pulling wire is smaller thanthe amount of an operation required to rotate the rotational roller. Bydoing so, the pulling wire can be wound slowly, and moreover the stentaccommodation cylindrical member 5 is allowed to move toward theproximal side of the stent-delivery device slowly and favorably. In thisembodiment, because the outer diameter of the winding shaft portion issmaller than that of the rotational roller, the winding amount of thepulling wire is allowed to be smaller than the amount of the operationrequired to rotate the rotational roller.

The outer diameter of the winding shaft portion 63 is favorably in therange of 1 to 60 mm and more favorably in the range of 3 to 30 mm. Theouter diameter of the rotational roller is favorably 1 to 20 times andmore favorably 1 to 10 times larger than that of the winding shaftportion. More specifically, the outer diameter of the rotational rolleris favorably in the range of 10 to 60 mm and more favorably in the rangeof 15 to 50 mm.

The rotational roller and the winding shaft portion does not necessarilyhave to be formed integrally, but the winding shaft portion may beconstructed of a separate member which follows the rotation of therotational roller. As the transmission system of the rotational roller,it is possible to use a gear type, a belt type, and the like. It ispreferable that surfaces of parts which have a possibility of contactwith the surface of the rotational roller 61 in operating the rotationalroller 61 is not slippery. For example, it is preferable to treatsurfaces of parts which have a possibility of contact with the surfaceof the rotational roller 61 in operating the rotational roller 61 byknurling treatment, emboss treatment application of a high-frictionalmaterial, and the like.

The operation portion 100 of the stent delivery device has the lockingmechanism for releasably locking the rotation of the pulling wirewinding mechanism, and the reverse rotation prevention mechanism forpreventing the rotation of the pulling wire winding mechanism in adirection opposite to a pulling wire winding direction.

As shown in FIGS. 41 through 43, the rotational roller 61 has the gearportion 62 which is coaxial therewith and rotates together therewith. Asshown in FIG. 43, the gear portion 62 is provided on the other sidesurface (in other words, surface opposite to surface on which windingshaft portion 63 is provided) of the rotational roller 61. Thus the gearportion 62 and the winding shaft portion 63 are partitioned from eachother by a wall constructed of the rotational roller.

The rotational roller 61 has the portion partly exposed from the openportion 98. The exposed portion serves as the operation portion. Theroller 61 has other end 64 a provided on one side surface (side surfaceof gear) of the rotating shaft thereof and the one end 64 b provided onthe other side surface (side surface of winding shaft) thereof.

An urging means 92 for urging the rotational roller 61 toward the openportion 98 of the housing 101 is provided inside the housing 101. Morespecifically, an urging member 92 b of the urging means 92 urges theroller 61. The housing 101 accommodates the locking rib 99 capable ofpenetrating into the gap between adjacent projected portions formed onthe gear portion 62 of the roller 61. Therefore the rotating roller 61has a state shown in FIG. 42, when the rotating roller 61 is urged bythe urging member 92 b. Thus the locking rib 99 engages the projectedportion of the gear portion 62. Thus the rotating roller 61 is incapableof rotating. When the rotating roller 61 is pressed in the direction inwhich it moves away from the locking rib 99, the one end 64 b and otherend 64 a of the rotating shaft of the roller 61 move inside the bearingportions 94 b and 94 a respectively provided in the housing 101. Therebythe rotational roller 61 becomes rotatable. Thus the operation portion100 of this embodiment prevents the rotation of the rotational roller61, when it is not pressed and has the locking mechanism for releasablylocking the rotation of the pulling wire winding mechanism.

The operation portion of this embodiment has the reverse rotationprevention mechanism composed of the urging means 92 having the urgingmember 92 b and the above-described gear portion 62. The reverserotation prevention mechanism prevents the rotation of the pulling wirewinding mechanism in the direction opposite to the pulling wire windingdirection. The urging means 92 has the urging member 92 b and the fixingmember 92 a for fixing the urging member 92 b to the housing 101. As theurging member 92 b, a leaf spring is used. The leaf spring extends fromthe fixing member 92 a to a lower portion of the gear portion 62 throughthe rear (direction opposite to distal portion of operation portion) ofthe gear portion 62 in such a way that the distal end of the leaf springengages the projected portions disposed at the lower portion of the gearportion 62. Because the leaf spring is pressed against the gear portion62, with the leaf spring in contact therewith, as described above, theroller 61 is urged toward the open portion 98 of the housing. The roller61 is pressed as described above and the roller 61 is rotatable. Theroller 61 is rotatable in the direction (pulling wire-winding direction)shown with the arrow of FIG. 42. If an operation of rotating the roller61 in the opposite direction is performed, the projected portion of thegear portion 62 and the distal end of the urging member 92 b engage eachother. Thereby the rotation of the roller 61 is prevented. Thereby thereverse rotation prevention mechanism prevents the rotation of thepulling wire winding mechanism in the direction opposite to the pullingwire winding direction.

The diameter of the gear portion 62 is set smaller than that of therotational roller. The outer diameter of the gear portion 62 isfavorably in the range of 10 to 60 mm and more favorably in the range of1.5 to 50 mm. The number of cogs thereof is favorably in the range of 4to 200 and more favorably in the range of 4 to 70.

As shown in FIG. 43, in the operation portion 100, the urging member(leaf spring) 92 penetrates between the inner surface of the housing 101and the side surface of the rotational roller 61, and the distal endthereof contacts the gear portion 62. Therefore the movement of theurging member 92 b in a lateral direction is prevented by the innersurface of the housing 101 and the side surface of the rotational roller61.

The shaft of the collar member 102 of the operation portion 100 issupported with the pin 103 at its one end. The collar portion 104 at theother side of the collar member 102 accommodates the winding shaftportion 63 and forms an annular space between the collar portion 104 andthe winding shaft portion 63. The annular space is not very large andformed annularly between collar portion 104 and the outer surface of thewound wire. As shown in FIG. 43, a thick portion 102 a having a widthequal to or a little smaller than the inner-side dimension of thehousing 101 is formed at a portion, of the collar member 102, supportedwith the pin 103. The portion from the thick portion 102 a to the collarportion 104 is formed as a thin portion 102 b capable of penetratingbetween the inner surface of the housing 101 and the side surface of therotational roller 61. The thickness of the thin portion 102 b is setequally to or a little smaller than the dimension between the innersurface of the housing 101 and the side surface of the rotational roller61. Therefore the collar member 102 prevents a movement of therotational roller 61 in a lateral direction (horizontal direction)toward the winding shaft portion. Further the urging member 92 bprevents a movement of the rotational roller 61 toward the gear portion.Thereby the rotational roller 61 is prevented from shaking.

The method of using the stent delivery device 50 of the presentinvention is described below with reference to the drawings.

In most cases, initially as shown in FIGS. 24 and 25, one end of theguide wire implanted in a human body is inserted into the opening 24 ofthe distal-end member 25 to expose the guide wire (not shown) from theproximal-side opening 23. Thereafter the guide wire is inserted into aguide catheter (not shown) disposed in the human body. Thereafter thestent delivery device 50 is moved forward along the guide wire todispose a stent accommodation portion of the stent accommodationcylindrical member 5 in a desired stenosed portion.

After the rotational roller 61 of the operation portion 9 is pressed,the rotational roller is rotated in the direction shown with the arrowof FIG. 35. Thereby the stent accommodation cylindrical member 5 axiallymoves to the proximal side of the stent delivery device. At this time,the rear end surface of the stent 3 contacts the distal end surface ofthe stent-locking portion 22 of the distal-side tube 2 and is lockedthereto. Thereby as the stent accommodation cylindrical member 5 moves,the stent 3 is discharged from the opening at the distal end of thestent accommodation cylindrical member 5. As shown in FIG. 31, owing tothe discharge, the stent 3 self-expands, expands the stenosed portion,and is implanted therein.

A stent delivery device 60 of another embodiment of the presentinvention is described below.

FIG. 37 is a schematic enlarged outlook view showing a neighborhood ofthe distal portion of the stent delivery device of another embodiment ofthe present invention.

The enlarged sectional view of FIG. 37 showing the neighborhood of thedistal portion of the stent delivery device is similar to that shown inFIG. 11. Thus FIG. 11 is referred to. The explanatory view forexplaining the action of the stent delivery device shown in FIG. 37 issimilar to that shown in FIG. 12. Thus FIG. 12 is referred to.

The stent delivery device 60 is the same as the stent delivery device 50except that the stent delivery device 60 does not have the intermediatetube and is different from that of the latter in the mode of thedistal-side tube. Other construction of the former is the same as thatof the latter. Thus the same parts of the former as those of the latterare denoted by the same reference numerals as those of the latter, anddescription thereof is omitted herein.

The stent delivery device 60 is the same as the stent delivery device 10in that the stent delivery device 60 does not have the intermediate tubeand is different from that of the latter in the mode of the distal-sidetube. Thus the stent delivery device 60 is described briefly withreference to the description of the stent delivery device 10.

The stent delivery device 60 of this embodiment has the distal-side tube2 a; the proximal-side tube 4; the stent accommodation cylindricalmember 5 a; the stent 3; and the pulling wire 6.

As shown in FIGS. 37, 11, and 12, as the stent accommodation cylindricalmember 5 a, a cylindrical member having almost the same diameter isused. A slit 59 as shown in FIG. 16 may be formed in the stentaccommodation cylindrical member 5 a. As shown in FIG. 16, a projectedportion 29 formed on the outer surface of the distal-side tube iscapable of advancing into the slit 59. In this embodiment, until thedistal end of the slit 59 contacts the projected portion 29, the stentaccommodation cylindrical member 5 a is movable toward the proximal sideof the stent delivery device. Thus the length of the slit 59 is setequal to or a little longer than the length in the range from theproximal end of the stent 3 accommodated in the stent accommodationcylindrical member 5 a to the distal end of the stent accommodationcylindrical member 5 a. As shown in FIG. 12, owing to the discharge fromthe stent accommodation cylindrical member 5, the stent 3 self-expandsand expands the stenosed portion and is implanted therein.

The stent accommodation cylindrical member 5 a is the same as that ofthe stent delivery device 1 of the above-described embodiment. The stent3 is accommodated in the stent accommodation cylindrical member 5 a atits distal portion. The stent 3 is the same as that of the stentdelivery device 1 of the above-described embodiment.

As shown in FIGS. 37, 11, and 12, the distal-side tube 2 a is a tubularbody having the guide wire lumen 21 penetrating through the distal-sidetube 2 a from its distal end to its proximal end. The distal-side tube 2a has a distal portion formed by a distal-end member 25 fixed to thedistal end thereof and has a distal-end opening 24. The distal portionformed by the distal-end member 25 may be formed integrally with thedistal-side tube 2 a. The distal-side tube 2 a is the same as that ofthe stent delivery device 1 of the above-described embodiment.

In this embodiment, the outer diameter of the proximal-side tube 4 isalso set smaller than a portion, having a maximum diameter, which isdisposed in a region of the stent delivery device 60 distal from theproximal-side tube 4. More specifically, in this embodiment, the outerdiameter of the stent accommodation cylindrical member 5 a is setmaximum. The outer diameter of the proximal-side tube 4 is set smallerthan the outer diameter of the stent accommodation cylindrical member 5a. As shown in FIGS. 37 and 11, in this embodiment, the distal portionof the proximal-side tube 4 is fixed to the proximal portion of thedistal-side tube 2 a by shifting the axis of the proximal-side tube 4 ina direction away from the proximal-side opening 23 with respect to theaxis of the distal-side tube 2 a.

The distal-side tube 2 a extends from the vicinity of the fixing point 6d at which the pulling wire 6 and the stent accommodation cylindricalmember 5 a are fixed to each other to the proximal side of the stentdelivery device. The distal-side tube 2 a has a passage 27 for thepulling member. In this embodiment, the passage 27 for the pullingmember is formed of a concave portion extended axially on the outersurface of the distal-side tube 2 a. The passage 27 for the pullingmember may be a lumen extended in penetration through the wall of thedistal-side tube 2 a.

In the stent delivery device 60 of this embodiment, by operating therotational roller 61 of the operation member 9 of the pulling wire 6toward the proximal end of the stent delivery device, the stentaccommodation cylindrical member 5 a axially moves to the proximal sideof the stent delivery device. At this time, the rear end surface of thestent 3 contacts the proximal end 26 a of the small-diameter portion 26of the distal-side tube 2 a and is locked thereto. Thereby as the stentaccommodation cylindrical member 5 a moves, the stent 3 is dischargedfrom the opening at the distal end of the stent accommodationcylindrical member 5 a. As shown in FIG. 12, the stent 3 self-expandsand expands the stenosed portion and is implanted therein.

In all the above-described embodiments, a plurality of (morespecifically, two) the pulling members may be provided.

A stent delivery device 70 shown in FIGS. 38 through 40 has tow pullingwires.

FIG. 38 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention. FIG. 39is an enlarged sectional view taken along a line L-L of FIG. 38. FIG. 40is an enlarged sectional view taken along a line M-M of FIG. 38.

The stent delivery device 70 is the same as the stent delivery device 50except that the stent delivery device 70 has two pulling members andthat there are some differences generated caused thereby. Otherconstruction of the former is the same as that of the latter. Thus thesame parts of the former as those of the latter are denoted by the samereference numerals as those of the latter, and description thereof isomitted herein. The above-described stent delivery device 60 may beprovided with two pulling wires. The construction having two pullingwires is the same as that of the above-described stent delivery device20.

As shown in FIGS. 38 and 39, the stent accommodation cylindrical member5 of the stent delivery device 70 has two slits 52 a, 52 b extended fromthe proximal end of the stent accommodation cylindrical member 5 towardits distal end and disposed at positions opposed to each other. Incorrespondence to the positions of the slits 52 a, 52 b, the distal-sidetube 2 has two tubular members 8 a, 8 b formed at positions opposed toeach other.

Two pulling members 6 a, 6 b are fixed to the proximal portion of thestent accommodation cylindrical member 5 at positions opposed to eachother. As shown in FIGS. 38 through 40, the pulling wire 6 a extendsinside the proximal-side tube 4 in penetration through the tubularmember 8 a and fixed to the winding shaft of the operation portion 9 atthe proximal portion thereof. Similarly the pulling wire 6 b extendsinside the proximal-side tube 4 in penetration through the tubularmember 8 b and fixed to the winding shaft of the operation portion 9 atthe proximal portion thereof. When the two pulling members 6 a, 6 b areused, they may be integrated with each other at the proximal portion ofthe stent accommodation cylindrical member 5.

In the stent delivery device of the present invention, it is possible toprevent the movement of the stent toward the distal end thereof and easyto insert the stent delivery device to a desired portion of an organ,provided that the distal-side tube of the stent delivery device has aprojected portion for preventing the movement of the stent, which isprovided at the side distal from the distal end of the stent andprovided that the distal side of the above-described projected portionis gradually decreased in its diameter toward the distal end thereof.

In the stent delivery device of the present invention, it is possible topull a pulling wire favorably, provided that the stent delivery devicehas a member, for maintaining the position of the pulling wire, which isdisposed on the outer surface of the distal-side tube and has a passagethrough which the pulling wire is capable of penetrating.

In the stent delivery device of the present invention, it is possible tomove the stent accommodation cylindrical member to move favorably towardthe proximal side of the stent delivery device, provided that aprojected portion is provided on an outer surface of the distal-sidetube and that the stent accommodation cylindrical member has a slitwhich extends from a distal end thereof toward a distal side thereof andinto which the projected portion is capable of moving.

In the stent delivery device of the present invention, it is possible toprevent the stent accommodation cylindrical member from movingexcessively, provided that the stent delivery device has a portion forrestricting a movement distance of the stent accommodation cylindricalmember toward the proximal side of the stent delivery device.

A stent delivery device of another embodiment of the present inventionis described below.

FIG. 44 is a partially schematic front view showing a stent deliverydevice of an embodiment of the present invention. FIG. 45 is an enlargedoutlook view showing the neighborhood of the operation portion of thestent delivery device shown in FIG. 44. FIG. 46 is an enlarged left-handside view showing the neighborhood of the operation portion of the stentdelivery device shown in FIG. 44. FIG. 47 is an enlarged bottom viewshowing the operation portion of the stent delivery device shown in FIG.44. FIG. 48 is a sectional view taken along a line O-O of FIG. 46. FIG.49 is an enlarged sectional view taken along a line P-P of FIG. 48. FIG.50 and FIG. 51 are an explanatory view for explaining the operation ofthe stent delivery device of the present invention.

The basic construction of a stent delivery device 80 is the same as thatof the stent delivery device 50 of the above-described embodiment. Inthe stent delivery device 80 of this embodiment, at the proximal portionof the proximal-side tube 4, the stent delivery device 80 includes anoperation portion 89 having a pulling wire winding mechanism for windingthe pulling wire 6 and moving the stent accommodation cylindrical member5 to the proximal side of the stent delivery device and a wire windingamount restriction mechanism for restricting the length of a wire woundby the pulling wire winding mechanism.

According to the stent delivery device 80 of the present invention usinga self-expandable stent the opening at the proximal side thereof isdisposed not at the proximal end thereof, but at the proximal side ofthe distal-side tube. Therefore in a stent-implanting operation, it iseasy to perform an operation of exchanging the stent delivery devicewith a stent delivery device of other type. By pulling the pulling wireto the proximal side of the stent delivery device, the stent can bedischarged from the stent accommodation cylindrical member. Thus theposition movement amount of the stent is very small in an operation ofdischarging the stent from the stent accommodation cylindrical member.Further the wire for pulling the bound stent to the proximal side of thestent delivery device is prevented from being excessively wound. Thus acatheter is prevented from being curved or damaged.

An operation portion 89 has a housing 91 (91 a, 91 b). It is preferablethat the pulling wire winding mechanism has a rotational roller 61 foroperational use (hereinafter referred to as merely rotational roller 61)having a portion exposed from the housing 91 and that by rotating therotational roller 61, the pulling wire 6 is wound on the rotationalroller 61 at its proximal side. This construction allows the operationportion 89 to be compact and an operation of rotating the rotationalroller to be accomplished, with the housing 91 being held with a hand.Thus it is possible to perform an operation of discharging the stentfrom the stent delivery device with one hand.

It is preferable that in a stent delivery device 80, the outer diameterof the proximal-side tube is set smaller than that of the portion,having the maximum diameter, which is disposed in the region of thestent delivery device 80 distal from the proximal-side tube 4. In thisconstruction, even in a state in which the guide wire is extended alongthe side surface of the proximal-side tube from the opening at theproximal side of the stent delivery device to the proximal side of thestent delivery device, the outer diameter of the proximal-side tube isset almost equally to that of the portion, having the maximum diameter,which is disposed in the region of the stent delivery device distal fromthe proximal-side tube. Thereby the stent can be inserted into a narrowblood vessel.

The stent delivery device 80 of this embodiment has the distal-side tube2, the proximal-side tube 4, the stent accommodation cylindrical member5, the stent 3, the pulling wire 6, and an operation portion 89 having amechanism for winding the pulling wire 6 and the wire winding amountrestriction mechanism.

The stent delivery device 80 of this embodiment has an intermediate tube7 that encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 and isfixed at a proximal portion thereof to the proximal portion of thedistal-side tube 2 and the distal portion of the proximal-side tube 4.In the stent delivery device 80 of this embodiment, the intermediatetube 7 encloses the proximal side of the distal-side tube 2 and theproximal side of the stent accommodation cylindrical member 5 withoutpreventing the stent accommodation cylindrical member 5 from movingtoward the proximal side of the stent delivery device 80. The one endportion of the pulling wire 6 is fixed to the stent accommodationcylindrical member 5 inside the intermediate tube 7. The pulling wire 6passes between the intermediate tube 7 and the distal-side tube 2 andextends into the proximal-side tube 4. This construction is preferablein that the pulling wire is not exposed.

The stent accommodation cylindrical member 5 is the same as that of thestent delivery device 1 of the above-described embodiment. As the stent3, it is possible to use the self-expandable stent of any types. Forexample, it is possible to preferably use the stent 3 of the stentdelivery device 1 of the above-described embodiment. As shown in FIGS.24 through 29, the distal-side tube 2 is a tubular body having the guidewire lumen 21 penetrating through the distal-side tube 2 from its distalend to its proximal end. The distal-side tube 2 has a distal portionformed by a distal-end member 25 fixed to the distal end thereof and hasa distal-end opening 24. The distal-side tube 2 is the same as that ofthe stent delivery device 1 of the above-described embodiment. Thedistal-end member 25 is also the same as that of the stent deliverydevice 1 of the above-described embodiment. As shown in FIG. 26, thedistal-side tube 2 has the stent-locking portion 22 for preventing thestent 3 from moving to the proximal side of the stent delivery device 1.The stent-locking portion 22 is the same as that of the stent deliverydevice 1 of the above-described embodiment.

As shown in FIGS. 24 through 29, the proximal-side tube 4 is a tubularbody extending from its distal end to its proximal end and has the hub42 fixed to its proximal end. The enlarged outlook view of FIG. 44showing the distal end of the stent delivery device and the vicinitythereof is similar to that shown in FIG. 25. Thus FIG. 25 is referredto. The enlarged sectional view of FIG. 44 showing the distal end of thestent delivery device and the vicinity thereof is similar to that shownin FIG. 26. Thus FIG. 26 is referred to. The distal portion of theproximal-side tube 4 is joined with the proximal portion of thedistal-side tube 2. The proximal-side tube 4 has therein the lumen 41into which the pulling wire 6 can be inserted. The proximal-side tube 4is the same as that of the stent delivery device 1 of theabove-described embodiment.

The stent delivery device 80 of this embodiment has the intermediatetube 7 which encloses the proximal side of the distal-side tube 2 andthe proximal side of the stent accommodation cylindrical member 5 and isfixed at the proximal portion thereof to the proximal portion of thedistal-side tube 2 and the distal portion of the proximal-side tube 4.In the stent delivery device 80 of this embodiment the intermediate tube7 encloses the proximal side of the distal-side tube 2 and the proximalside of the stent accommodation cylindrical member 5 without preventingthe stent accommodation cylindrical member 5 from moving toward theproximal side of the stent delivery device 80. The one end portion ofthe pulling wire 6 is fixed to the stent accommodation cylindricalmember 5 inside the intermediate tube 7. The pulling wire 6 passesbetween the intermediate tube 7 and the distal-side tube 2 and extendsinto the proximal-side tube 4.

The proximal portion of the distal-side tube 2 extends inside theintermediate tube 7 and is exposed from the proximal end of theintermediate tube 7. The distal portion of the proximal-side tube 4penetrates into the proximal portion of the intermediate tube 7. At theproximal portion of the intermediate tube 7, the distal-side tube 2, theproximal-side tube 4, and the intermediate tube 7 are liquid-tightlyfixed. The lumen 41 inside the proximal-side tube 4 communicates withthe inside of the intermediate tube 7. As shown in FIGS. 2 and 3, thedistal portion of the intermediate tube 7 is decreased in its diameteror curved. It is preferable that the distal end of the intermediate tube7 liquid-tightly contacts the outer surface of the stent accommodationcylindrical member 5 without preventing the movement of the stentaccommodation cylindrical member 5. But the distal end of theintermediate tube 7 does not necessarily have to contact the outersurface of the stent accommodation cylindrical member 5. Theintermediate tube is the same as that of the stent delivery device 1 ofthe above-described embodiment.

The stent delivery device 80 has the pulling wire 6 extending inside theproximal-side tube 4, with one end portion thereof fixed to the stentaccommodation cylindrical member 5 and being pulled toward the proximalside of the proximal-side tube 4 to move the stent accommodationcylindrical member 5 to the proximal side of the stent delivery device.The pulling wire 6 is the same as that of the stent delivery device 1 ofthe above-described embodiment.

The stent delivery device 80 of this embodiment has the projectedportion (tubular member) 8 provided on the outer surface of thedistal-side tube 2 at its proximal side. The projected portion 8(tubular member) is capable of moving inside the slit 52 of the stentaccommodation cylindrical member 5. The projected portion 8 (tubularmember) is the same as that of the stent delivery device 1 of theabove-described embodiment. The slit 52 is also the same as that of thestent delivery device 80 of the above-described embodiment. The stentdelivery device 1 of this embodiment may have a movement distancerestriction portion for restricting a movement distance of the stentaccommodation cylindrical member 5 toward the proximal side of the stentdelivery device. More specifically, owing to the movement of the stentaccommodation cylindrical member 5 toward the proximal side of the stentdelivery device, the projected portion (in this embodiment, tubularmember though which wire penetrates) 8 contacts the distal end of theslit 52, thus preventing a further movement of the stent accommodationcylindrical member 5 toward the proximal side of the stent deliverydevice.

The stent delivery device 80 of this embodiment has a member for holdingthe position of the pulling wire. This member is disposed on the outersurface of the distal-side tube 2 and has a passage through which thepulling wire 6 is capable of penetrating. The stent delivery device ofthis embodiment has a tubular member 8 displaying the function of themember for holding the position of the pulling wire and the function ofthe above-described projected portion. The member for holding theposition of the pulling wire is the same as that of the stent deliverydevice 1 of the above-described embodiment.

As shown in FIGS. 44, 45, 46 through 51, the stent delivery device 80 ofthe present invention has a operation portion 89 fixed to at theproximal end of the proximal-side tube 4, namely, to a hub 42 providedat the proximal end of the proximal-side tube 4.

The operation portion 89 of the stent delivery device 80 has the wirewinding amount restriction mechanism in addition to the pulling wirewinding mechanism. Further the operation portion 89 of the stentdelivery device 80 has the locking mechanism for releasably locking therotation of the pulling wire winding mechanism, and the reverse rotationprevention mechanism for preventing the rotation of the pulling wirewinding mechanism in the direction opposite to the pulling wire windingdirection.

The operation portion 89 has the housing 91 composed of the body 91 aand the covering member 91 b sealing the open portion of the body 91 a.The connector 93 which is connected with the hub 42 is fixed to thedistal portion of the housing 91. The housing 91 has the pulling wirepassage 97 extended from the distal end of the distal portion thereof tothe inside thereof. The connector 93 is fixed to the distal portion ofthe housing 91 by means of the fixing member 96 in such a way that apassage inside the connector 93 communicates with the pulling wirepassage 97.

As shown in FIGS. 45, 46, and 49, the connector 93 includes a hollowbody 93 a, a connection port 93 b extended from the body 93 a, and asealing member 93 d holding the pulling wire 6 slidably andliquid-tightly. The connection port 93 b is mounted at the proximalportion of the hub 42 of the proximal-side tube 4. The connector 93 mayhave a side port 93 c communicating with the inside of the body thereof.

The operation portion 89 of the stent delivery device 80 is the same asoperation portion 9 of the stent delivery device 50 of theabove-described embodiment except that the construction of the wirewinding amount restriction mechanism of the former is different fromthat of the latter.

As shown in FIGS. 44 through 51, the stent delivery device of thisembodiment has the wire winding amount restriction mechanism. The wirewinding amount restriction mechanism of this embodiment is constructedof a linear member 71, having a predetermined length whose one end 71 bis held by the operation portion. The other end 71 a of the linearmember 71 is fixed to the winding shaft portion 63 of the rotationalroller 61 or a linear member-winding shaft portion (not shown) providedseparately from the winding shaft portion. After a predetermined amountof the linear member 71 is wound around the winding shaft portion 63 oraround the linear member-winding shaft portion by the rotation of therotational roller 61 in a wire-winding direction, the linear member 71cannot further wound.

More specifically, the operation portion 89 accommodates a bobbin 73 onwhich the linear member 71 is wound, with one end 71 b of the linearmember 71 held thereby. As exemplified in FIG. 58, the bobbin 73 has arotational shaft having two end portions 73 a, 73 b. The bobbin 73 canbe rotated by the rotation of the rotational shaft. The bobbin 73further has an annular groove 74 on which the linear member is wound anda groove or a hole 75 communicating with the annular groove 74. Theother end 71 a of the linear member 71 is held by the winding shaftportion 63 of the rotational roller 61. More specifically, the other endof the linear member is inserted into a slit 72 (see FIG. 48) formed onthe rotational roller 61, and the other end 71 a bulged in a widthlarger than the width of the slit 72 is held by the winding shaftportion 63.

Therefore as shown in FIGS. 50 and 51, when the rotational roller 61 isrotated in the direction in which the pulling wire 6 is wound, thepulling wire held by the winding shaft portion 63 is wound thereon, andthe linear member 71 held by the winding shaft portion 63 is also woundthereon. When the linear member wound around the bobbin is all fed outas a result of rotation of the bobbin 73 with the progress of thewinding of the linear member 71, the bobbin is nonrotatable. Thereby therotational roller is incapable of further rotating. Thus the pullingwire is prevented from being excessively pulled.

In this embodiment, the linear member 71 is wound around the windingshaft portion 63. But in addition, it is possible to provide therotational roller 61 with the linear member winding shaft separatelyfrom the winding shaft portion 63 and wind the linear member around thelinear member winding shaft.

It is preferable that the winding effective length (in other words,length of the rotational roller that can be wound around shaft portion)of the linear member 71 is a little longer than the axial length of thestent. When not only the pulling wire but also the linear member 71 iswound around the winding shaft portion 63, the winding amount of thepulling wire and that of the linear member for the rotational roller areequal to each other. Thus the winding effective length of the linearmember can be set easily.

As the material for forming the linear member 71, any materialsdifficult to break can be preferably used. Further materials difficultto stretch can be also preferably used. Thus the following substancescan be used: stainless steel wire (preferably, high tensile stainlesswire for spring); music wire (preferably, nickel-plated orchromium-plated music wire); super-elastic alloy wire; wires made ofmetal such as Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungstenalloy, titanium, titanium alloy, cobalt alloy; tantalum, comparativelyhigh rigidity polymeric materials such as polyamide, polyimide,ultra-high-molecular-weight polyethylene, polypropylene, andfluororesin; and combinations of these substances.

The wire winding amount restriction mechanism is not limited to the onedescribed in the above-described embodiment provided that a wire windingamount restriction mechanism restricts the winding amount of the wire tobe pulled by the pulling wire winding mechanism. The above-describedwire winding amount restriction mechanism of the above-described typerestricts the rotatable amount of the rotational roller. The operationportion 100 shown in FIGS. 53 and 54 is capable of serving as the wirewinding amount restriction mechanism of this type.

The operation portion 100 serving as the wire winding amount restrictionmechanism includes a projected portion 81 and a locking portion 82 withwhich the rotational roller 61 provided in the operation portion 100contacts after it rotates in a predetermined amount in the wire-windingdirection and which prevents a further rotation of the rotational roller61.

In the operation portion 100, when the rotational roller 61 is rotatedin a direction with the arrow of FIG. 54, the pulling wire 6 is wound.But when the projected portion 81 contacts the locking portion 82, theroller 61 cannot be rotated further. Thus the pulling wire cannot bewound further. In this operation portion, the length of the wire to bepulled by the pulling wire winding mechanism is restricted. Thisoperation portion also restricts the rotatable amount of the rotationalroller.

The position of the projected portion 81 of the wire winding amountrestriction mechanism of this embodiment can be adjusted in therotational roller 61. Therefore the rotatable amount of the rotationalroller 61 can be adjusted. More specifically, a plurality of concaveportions 84 is formed on the surface of the rotational roller 61. In theembodiment, the concave portions 84 are formed at regular intervals. Theprojected portion 81 is removably mounted on the concave portions 84.Thus a concave portion at an arbitrary position can be selected. Therebythe rotatable amount of the rotational roller 61 can be adjusted.

In the above-described embodiment, the projected portions 81 are formedon the outer surface of the rotational roller in a direction in whichthey project from the outer surface of the rotational roller. But theymay be formed on a flat plane. In this case, the locking portion isprovided at a position corresponding to that of the projected portion.

The operation portion may be constructed as shown in FIGS. 55 through58.

FIG. 55 is an enlarged front view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention. FIG. 56 is a rear side view showing theneighborhood of the operation portion of the stent delivery device shownin FIG. 55. FIG. 57 is an explanatory view for explaining an internalconstruction of the neighborhood of an operation portion of the stentdelivery device shown in FIG. 55. FIG. 58 is an explanatory view forexplaining the internal construction of the neighborhood of theoperation portion of the stent delivery device shown in FIG. 55.

The basic construction of an operation portion 200 of this embodiment isthe same as that of the above-described operation portion 100. Theoperation portion 200 is different from the operation portion 100 in theconfiguration of a housing shown in FIG. 58, the position of the windingshaft portion 63 and that of the gear portion 62 with respect to therotational roller 61, the operation portion 200 has a collar member 102,the operation portion 200 is provided with a sealing member 88, and theoperation portion 200 has a bobbin accommodation portion 202.

As shown in FIGS. 55 through 58, an operation portion 200 has a housing201. The housing 201 is constructed of a first housing 201 a and asecond housing 201 b. The proximal side and central portion of thehousing 201 is bent and rounded. This configuration allows the housing201 to be held easily and the roller to be operated easily.

A connector 93 is fixed to the proximal end of the proximal-side tube 4.The connector 93 accommodates a sealing member 93 d sealing the pullingwire 6 slidably and liquid-tightly. The proximal portion of theproximal-side tube 4 projects from the proximal portion of the connector93 and is liquid-tightly fixed by means of a sealing member 88 disposedinside the operation portion 200. The proximal end of the proximal-sidetube 4 penetrates through the sealing member 88. As in the case of theabove-described operation portion 9, a wire protection tube may beprovided. The housing 201 has a connector-mounting portion at its distalportion. As shown in FIG. 57, the proximal side of the connector 93 isfixedly accommodated in the connector-mounting portion.

The above-described materials can be used to compose the housing 201 ofthe operation portion and the connector 93. As materials for the sealingmember 88, the sealing member 93 d, and the wire protection tube, theabove-described elastic materials are used.

As shown in FIGS. 55 through 58, the housing 201 includes an openportion for partly projecting the rotational roller 61, a locking rib 99engaging projected portions of a gear portion 62 (see FIG. 56) providedon the roller 61, a bearing portion 94 b accommodating one end 64 b ofthe rotating shaft of the roller 61, and a bearing portion 94 aaccommodating the other end 64 a of the rotating shaft of the roller 61.The locking rib 99 is so configured that it is capable of penetratinginto the gap between adjacent projected portions formed on the gearportion 62 of the roller 61. As shown in FIGS. 55 and 56, the bearingportions 94 a and 94 b accommodate the one end 64 b and the other end 64a of the rotating shaft of the roller 61 respectively and have the shapeof a gourd extended in a direction in which they recede from theabove-described locking rib 99. The bearing portions 94 a and 94 b arenot limited to the shape of the gourd, but may have configurations whichallow them to move a distance in which they are capable of disengagingfrom the locking rib. For example, the bearing portions 94 a and 94 bmay be rectangular, elliptic, and gourd-shaped. In the operation portion200 of the embodiment, the bearing portions 94 a and 94 b are gourdlike,as shown in FIGS. 55 and 56. Therefore the rotational roller 61 ispressed to allow the ends 64 b, 64 a of the rotating shaft of the roller61 accommodated in a space formed at one side of the bearing portions 94a, 94 b to ride across opposed rib portions formed on the inner sidesurface of the central portion of the bearing portions 94 a, 94 b.Thereby the ends 64 b, 64 a of the rotating shaft of the roller 61 areaccommodated in a space formed at the other side of the bearing portions94 a, 94 b. The state of the roller 61 is shown with the broken line ofFIG. 56. In this state, the roller 61 is pressed by the urging member.Thereby the ends 64 b, 64 a of the rotating shaft of the roller 61contact opposed ribs formed on the inner side surface of the centralportion of the bearing portions 94 a, 94 b and thus do not move to thespace formed at the one side of the bearing portions 94 a, 94 b.Therefore the roller 61 keeps a rotatable state.

In this embodiment, as shown in FIGS. 57 and 58, the operation portion200 has a collar member 102. The collar member 102 accommodates thewinding shaft portion 63 and has a collar portion 104 forming an annularspace between it and the winding shaft portion 63. The collar portion104 prevents the pulling wire wound around the winding shaft portion 63from becoming loose. The collar member 102 has a function of guiding therotational roller in its movement and suppressing shaking of therotational roller when the rotational roller is pressed. The shaft ofthe collar member 102 is supported with a pin 103. Thus as shown inFIGS. 55 and 56, the bearing portions 94 a, 94 b are formed in the shapeof a gentle circular arc about the pin 103. The bearing portions 94 aand 94 b have the length allowing the roller 6 to move a distance longerthan the height of the locking rib 99. As shown in FIG. 58, the collarmember 102 has two opposed cut-out portions 105 which reach the spaceinside the collar portion 104 from the side surface thereof. The pullingwire 6 penetrates through one of the cut-out portions 105 and is fixedto the winding shaft portion 63. The linear member 71 penetrates throughthe other cut-out portion 105 and is fixed to the winding shaft portion63.

The pulling wire winding mechanism is constructed of the roller 61 andthe winding shaft portion 63 which is rotated by the rotation of theroller 61. The proximal portion of the pulling wire 6 is held by thewinding shaft portion 63 or secured thereto. More specifically, as shownin FIG. 57, an anchoring portion 65 larger than the wire 6 is providedat the proximal portion of the pulling wire 6. A slit 63 a capable ofaccommodating the pulling wire 6 is formed in the winding shaft portion63. The slit 63 a of the winding shaft portion 63 accommodates theproximal portion of the pulling wire 6, with the anchoring portion 65disposed outward from the slit 63 a. Thereby when the winding shaftportion 63 having the above-described construction rotates, the wire 6is wound on the outer surface thereof. The method of holding theproximal portion of the pulling wire 6 on the winding shaft portion 63or securing the pulling wire 6 thereto is not limited to theabove-described method, but any methods can be used. For example, theproximal end of the pulling wire 6 or the proximal portion thereof maybe directly secured to the winding shaft.

It is preferable that the proximal portion of the pulling wire 6 to bewound on the winding shaft portion 63 is soft to allow the pulling wire6 to be wound easily. To make the proximal portion of the pulling wire 6flexible, it is possible to adopt a method of making the proximalportion of the pulling wire 6 of a flexible material and a method ofdecreasing the diameter of the proximal portion of the pulling wire 6.

In this embodiment, the winding shaft portion 63 is formed integrallywith the rotational roller 61 to make the winding shaft portion 63 andthe rotational roller 61 coaxial with each other. As shown in FIG. 55,the winding shaft portion 63 is provided on one side surface of therotational roller 61. Thus by rotating the rotational roller 61, thewinding shaft portion 63 rotates simultaneously therewith. It ispreferable that the winding amount of the pulling wire is smaller thanthe amount of an operation required to rotate the rotational roller. Bydoing so, the pulling wire can be wound slowly, and moreover the stentaccommodation cylindrical member 5 is allowed to move toward theproximal side of the stent delivery device slowly and favorably. In thisembodiment, because the outer diameter of the winding shaft portion issmaller than that of the rotational roller, the winding amount of thepulling wire is allowed to be smaller than the amount of the operationrequired to rotate the rotational roller.

The outer diameter of the winding shaft portion 63 is favorably in therange of 1 to 60 mm and more favorably in the range of 3 to 30 mm. Theouter diameter of the rotational roller is favorably 1 to 20 times andmore favorably 1 to 10 times larger than that of the winding shaftportion. More specifically, the outer diameter of the rotational rolleris favorably in the range of 10 to 60 mm and more favorably in the rangeof 15 to 50 mm.

The rotational roller and the winding shaft portion do not necessarilyhave to be formed integrally, but the winding shaft portion may beconstructed of a separate member which follows the rotation of therotational roller. As the transmission system of the rotational roller,it is possible to use a gear type, a belt type, and the like. It ispreferable that surfaces of parts which have a possibility of contactwith the surface of the rotational roller 61 in operating the rotationalroller 61 is not slippery. For example, it is preferable to treatsurfaces of parts which have a possibility of contact with the surfaceof the rotational roller 61 in operating the rotational roller 61 byknurling treatment, emboss treatment, application of a high-frictionalmaterial, and the like.

The other end of the linear member 71 is held by the winding shaftportion 63 or secured thereto. More specifically, as shown in FIGS. 57and 58, a bulged portion (in other words, anchoring portion) 71 a largerthan the linear member 71 is provided at the other end portion of thelinear member 71. A slit 72 capable of accommodating the linear member71 is formed in the winding shaft portion 63. The slit 72 accommodatesthe other end portion of the linear member 71, with the anchoringportion 71 a disposed outward from the proximal end of the slit 72.Thereby when the winding shaft portion 63 having the above-describedconstruction rotates, the linear member 71 is wound on the outer surfacethereof. The method of holding the linear member 71 on the winding shaftportion 63 or securing the linear member 71 thereto is not limited tothe above-described method, but any methods can be used. For example,the proximal end of the linear member 71 or the proximal portion thereofmay be directly secured to the winding shaft.

It is preferable that the portion of the linear member 71 to be wound onthe winding shaft portion 63 is soft to allow the linear member 71 to bewound easily. To make the proximal portion of the linear member 71flexible, it is possible to adopt a method of making the portion of thelinear member 71 to be wound of a flexible material and a method ofdecreasing the diameter of the portion of the linear member 71 to bewound.

In this embodiment the winding shaft portion 63 is formed integrallywith the rotational roller 61 to make the winding shaft portion 63 andthe rotational roller 61 coaxial with each other. As shown in FIG. 55,the winding shaft portion 63 is provided on one side surface of therotational roller 61. By rotating the rotational roller 61, the windingshaft portion 63 rotates simultaneously therewith. It is preferable thatthe winding amount of the linear member is smaller than the amount of anoperation required to rotate the rotational roller. By doing so, thelinear member can be wound slowly.

In this embodiment, the linear member 71 is wound around the windingshaft portion 63. But in addition, it is possible to provide therotational roller 61 with the linear member winding shaft separatelyfrom the winding shaft portion 63 and wind the linear member around thelinear member winding shaft.

The operation portion 200 has a bobbin accommodation portion 202 whichis a cylindrical projected portion provided on the inner surface of thehousing 201 of the operation portion and rotatably accommodates thebobbin. A slit 202 a into which the linear member is inserted isprovided inside the bobbin accommodation portion. The bobbinaccommodation portion prevents the linear member 71 wound around thebobbin 73 from becoming loose. As shown in FIG. 58, the bobbin 73 has anannular groove 74 on which the linear member is wound and groove or ahole 75 communicating with the annular groove.

The operation portion 200 of this embodiment has the locking mechanismfor releasably locking a rotation of the pulling wire winding mechanism,and the reverse rotation prevention mechanism for preventing therotation of the pulling wire winding mechanism in the direction oppositeto the pulling wire winding direction.

As shown in FIGS. 55 and 56, the rotational roller 61 has the gearportion 62 which is coaxial therewith and rotates together therewith. Asshown in FIG. 56, the gear portion 62 is provided on the other sidesurface (in other words, surface opposite to surface on which windingshaft portion 63 is provided) of the rotational roller 61. Thus the gearportion 62 and the winding shaft portion 63 are partitioned from eachother by a wall constructed of the rotational roller.

The rotational roller 61 has the portion partly exposed from the openportion 98. The exposed portion serves as the operation portion. Theroller 61 has one end 64 a provided on one side surface (side surface ofgear) of the rotating shaft thereof and the other end 64 b provided onthe other side surface (side surface of winding shaft) thereof.

The urging means 92 for urging the rotational roller 61 toward the openportion 98 of the housing 101 is provided inside the housing 201. Morespecifically, the urging member 92 b of the urging means 92 urges theroller 61. The housing 201 accommodates the locking rib 99 capable ofpenetrating into the gap between adjacent projected portions formed onthe gear portion 62 of the roller 61. Therefore the rotating roller 61has a state shown in FIG. 56, when the rotating roller 61 is urged bythe urging member 92 b. Thus the locking rib 99 engages the projectedportion of the gear portion 62. Thus the rotating roller 61 is incapableof rotating. When the rotating roller 61 is pressed in the direction inwhich it moves away from the locking rib 99, the one end 64 b and otherend 64 a of the rotating shaft of the roller 61 move inside the bearingportions 94 b and 94 a respectively provided in the housing 201. Therebythe rotational roller 61 becomes rotatable. Thus the operation portion200 of this embodiment prevents the rotation of the rotational roller 61when it is not pressed and has the locking mechanism for releasablylocking the rotation of the pulling wire winding mechanism.

The operation portion of this embodiment has the reverse rotationprevention mechanism composed of the urging means 92 having the urgingmember 92 b and the above-described gear portion 62. The reverserotation prevention mechanism prevents the rotation of the pulling wirewinding mechanism in the direction opposite to the pulling wire windingdirection. The urging means 92 has the urging member 92 b and the fixingmember 92 a for fixing the urging member 92 b to the housing 201. As theurging member 92 b, a springlike member is used. The springlike memberextends from the fixing member 92 a to a lower portion of the gearportion 62 through the rear (direction opposite to distal portion ofoperation portion) of the gear portion 62 in such a way that the distalend of the springlike member engages the projected portions disposed atthe lower portion of the gear portion 62. Because the springlike memberis pressed against the gear portion 62, with the springlike member incontact therewith, as described above, the roller 62 is urged toward theopen portion 98 of the housing. The roller 61 is pressed as describedabove and the roller 61 is rotatable. The roller 61 is rotatable in thedirection (pulling wire-winding direction) shown with the arrow of FIG.56. If an operation of rotating the roller 61 in the opposite directionis performed, the projected portion of the gear portion 62 and thedistal end of the urging member 92 b engage each other. Thereby therotation of the roller 61 is prevented. Thereby the reverse rotationprevention mechanism prevents the rotation of the pulling wire windingmechanism in the direction opposite to the pulling wire windingdirection.

The diameter of the gear portion 62 is set smaller than that of therotational roller. The outer diameter of the gear portion 62 isfavorably in the range of 10 to 60 mm and more favorably in the range of15 to 50 mm. The number of cogs thereof is favorably in the range of 4to 200 and more favorably in the range of 4 to 70.

As shown in FIG. 55, in the operation portion 200, the urging member 92penetrates between the inner surface of the housing 201 and the sidesurface of the rotational roller 61, and the distal end thereof contactsthe gear portion 62. Therefore the movement of the urging member 92 b ina lateral direction is prevented by the inner surface of the housing 201and the side surface of the rotational roller 61.

The shaft of the collar member 102 of the operation portion 200 issupported with the pin 103 at its one end. The collar portion 104 at theother side of the collar member 102 accommodates the winding shaftportion 63 and forms an annular space between the collar portion 104 andthe winding shaft portion 63. The annular space is not very large andformed annularly between collar portion 104 and the outer surface of thewound wire.

In the stent delivery devices 80 and 120, by rotating the roller in thedirection shown with the arrow of FIG. 51, the linear member 71 is woundaround the winding shaft portion 63. After a windable amount of thelinear member 71 is wound, it is impossible to perform an operation ofrotating the roller 61.

The stent delivery devices 80, 120 of this embodiment may have a modesimilar to that of the stent delivery device 10 of the above-describedembodiment. As described above, the stent delivery device 10 is the sameas the stent delivery device 1 except that the stent delivery device 10does not have the intermediate tube and that the mode of the distal-sidetube the former is different from the mode of the distal-side tube ofthe latter. Other construction of the former is the same as that of thelatter.

The stent delivery device 80 of this embodiment may have a plurality of(more specifically, two) the pulling members. A stent delivery device120 of the embodiments shown in FIGS. 52, 39, and 40 has two pullingwires. FIG. 52 is a partially schematic enlarged outlook view showing astent delivery device of another embodiment of the present invention.The sectional view taken along the line L-L shown in FIG. 52 is similarto that shown in FIG. 39. The sectional view taken along the line M-Mshown in FIG. 52 is similar to that shown in FIG. 40.

The stent delivery device 120 is the same as the stent delivery device80 except that the stent delivery device 120 has two pulling members andthat there are some differences generated caused thereby. Otherconstruction of the former is the same as that of the latter. Thus thesame parts of the former as those of the latter are denoted by the samereference numerals as those of the latter, and description thereof isomitted herein. The above-described stent delivery device 120 may beprovided with two pulling members.

As shown in FIGS. 52 and 39, the stent accommodation cylindrical member5 of the stent delivery device 120 has two slits 52 a, 52 b extendedfrom the proximal end of the stent accommodation cylindrical member 5toward its distal end and disposed at positions opposed to each other.In correspondence to the positions of the slits 52 a, 52 b, thedistal-side tube 2 has two tubular members 8 a, 8 b formed at positionsopposed to each other.

Two pulling members 6 a, 6 b are fixed to the proximal portion of thestent accommodation cylindrical member 5 at positions opposed to eachother. As shown in FIGS. 52, 39, and 40, the pulling member 6 a extendsinside the proximal-side tube 4 in penetration through the tubularmember 8 a and enters into the operation portion 90 at the proximalportion thereof. Similarly the pulling member 6 b extends inside theproximal-side tube 4 in penetration through the tubular member 8 b andfixed to the winding shaft of the operation portion 9 at the proximalportion of the stent accommodation cylindrical member 5.

In the stent delivery device of the present invention, it is possible topull a pulling wire favorably, provided that the stent delivery devicehas a member, for maintaining the position of the pulling wire, which isdisposed on the outer surface of the distal-side tube and has a passagethrough which the pulling wire is capable of penetrating.

In the stent delivery device of the present invention, it is possible tomove the stent accommodation cylindrical member to move favorably towardthe proximal side of the stent delivery device, provided that aprojected portion is provided on an outer surface of the distal-sidetube and that the stent accommodation cylindrical member has a slitwhich extends from a distal end thereof toward a distal side thereof andinto which the projected portion is capable of moving.

In all the above-described embodiments, a rigidity-imparting member (notshown) may be inserted into the proximal-side tube 4. It is preferablethat the proximal portion of the rigidity-imparting member is fixed tothe proximal-side tube and that the distal end of the rigidity-impartingmember is projected from the distal end of the proximal-side tube andextended to the inside the distal-side tube. It is preferable that onlythe proximal portion of the rigidity-imparting member is fixed to theproximal-side tube and other portions thereof are not fixed not toprevent the stent delivery device from curving. The rigidity-impartingmember serves as a means for preventing the proximal-side tube frombeing extremely bent at a portion to be bent and the proximal-side tubefrom zigzagging in a blood vessel without much deteriorating theflexibility of the proximal-side tube. It is preferable that therigidity-imparting member is made of a linear member. It is preferablethat the linear member is a metal wire. As the metal wire, an elasticmetal and a super-elastic alloy can be used. The diameter of the metalwire is in the range of 0.05 to 15 mm and favorably in the range of 0.1to 1.0 mm. A high tensile stainless steel wire for spring and asuper-elastic alloy wire are particularly favorable.

In all the above-described embodiments, the stent delivery devices havea rigidity-imparting member 11 respectively.

FIG. 59 is a partially schematic enlarged outlook view showing a stentdelivery device of another embodiment of the present invention. FIG. 60is an enlarged sectional view showing the neighborhood of a distalportion of the stent delivery device shown in FIG. 59. FIG. 61 is anenlarged sectional view taken along a line Q-Q of FIG. 59.

The basis constitution of the stent delivery device 150 of this exampleis substantially same with the stent delivery device 40 shown in FIGS.19 through 22 and mentioned above.

The stent delivery device 150 of this embodiment has therigidity-imparting member 11 separately from the above-described pullingwire (pulling member). As shown in FIGS. 59 and 60, therigidity-imparting member 11 extends from the proximal side of the stentdelivery device 150, passe inside the proximal-side tube, and penetratesinto the stent accommodation cylindrical member 5 b. As shown in FIGS.59 and 60, the distal end 11 a of the rigidity-imparting member 11 isfixed to the outer surface of the distal-side tube 2 by means of afixing portion 11 a. It is particularly preferable that the distal endof the rigidity-imparting member is fixed to the outer surface of thedistal-side tube 2 at a position of the distal side from the tip of theposition intermediate tube 47. It is preferable that therigidity-imparting member 11 is fixed to the proximal portion of theproximal-side tube 4 or the operation portion at the proximal portionthereof. The rigidity-imparting member 11 serves as a means forsuppressing deformation of the stent delivery device when the pullingmember (pulling wire) is pulled. A twisted wire material or a pluralityof twisted wire materials can be preferably used as the material forcomposing the rigidity-imparting member 11. The diameter of therigidity-imparting member 11 is in the range of favorably 0.01 to 1.5 mmand more favorably 0.1 to 1.0 mm.

As the material for forming the rigidity-imparting member 11, thefollowing substances can be used: stainless steel wire (preferably, hightensile stainless wire for spring); music wire (preferably,nickel-plated or chromium-plated music wire); super-elastic alloy wire;wires made of metal such as Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy,tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy,tantalum. It is preferable that the rigidity-imparting member 11 isharder than the pulling member (pulling wire).

The stent delivery device 150 shown in FIGS. 59 through 61 has anintermediate tube 7. A distal end of the intermediate tube 47 enters inthe cylindrical member 5 b. The intermediate tube 47 is fixed at theproximal portion thereof to the proximal portion of the distal-side tube2 and the distal portion of the proximal-side tube 4. In the stentdelivery device 150 of this embodiment the intermediate tube 7 enclosesthe proximal side of the distal-side tube 2 and the proximal side of thestent accommodation cylindrical member 5 b without preventing the stentaccommodation cylindrical member 5 from moving toward the proximal sideof the stent delivery device 1. The intermediate tube 7 is insertableinto the cylindrical member 5 b. The pulling members 6 a, 6 b pass theintermediate tube 47. Distal ends of the pulling members 6 a, 6 b enterinto the stent accommodation cylindrical member 5 b and are fixed to theinner surface of the accommodation cylindrical member 5 b at the middleportion of the member 5 b. The pulling member 6 passes between theintermediate tube 47 and the distal-side tube 2 and extends into theproximal-side tube 4. A space forming tube 49 is inserted between thestent accommodation cylindrical member 5 b and the distal-side tube 2.The space forming tube 49 is not fixed to the stent accommodationcylindrical member 5 b and the distal-side tube 2.

The rigidity-imparting member 11 passes inside the proximal-side tube 4,penetrates into the intermediate tube 47, penetrates into the spacebetween the stent accommodation cylindrical member 5 b and thedistal-side tube 2 from the read end of the stent accommodationcylindrical member 5 b, and extends toward the distal side of the stentaccommodation cylindrical member 5.

Similarly to the stent delivery devices 20, 40, 70, and 120 of theabove-described embodiments, the stent delivery device 150 of thisembodiment has two pulling wires. The construction of the stent deliverydevice 150 having two pulling wires is the same as that of the stentdelivery device 40 of the above-described embodiment.

Two pulling members 6 a, 6 b are fixed to the middle portion of thestent accommodation cylindrical member 5 b at positions opposed to eachother. As shown in FIGS. 38 through 40, the pulling wire 6 a extendsinside the proximal-side tube 4 in penetration through the intermediatetube 47 and fixed to the winding shaft of the operation portion 90 atthe proximal portion thereof. Similarly the pulling wire 6 b extendsinside the proximal-side tube 4 in penetration through the intermediatetube 47 and fixed to the winding shaft of the operation portion 90 atthe proximal portion thereof. When the two pulling members 6 a, 6 b areused, they may be integrated with each other at the proximal portion ofthe stent accommodation cylindrical member 5. As shown in FIG. 61, thetwo pulling members 6 a, 6 b are spaced at a predetermined intervalinside the stent accommodation cylindrical member 5 b. As shown in FIG.61, inside the stent accommodation cylindrical member 5 b, therigidity-imparting member 11 is spaced at an equal interval from thepulling wires 6 a and 6 b.

In all the above-described embodiments, the operation portion may beformed as shown in FIGS. 62 through 64.

FIG. 62 is an enlarged front view showing the neighborhood of anoperation portion of a stent delivery device of another embodiment ofthe present invention. FIG. 63 is an explanatory view for explaining aninternal construction of the neighborhood of the operation portion ofthe stent delivery device shown in FIG. 62. FIG. 64 is an explanatoryview for explaining an internal construction of the neighborhood of theoperation portion of the stent delivery device shown in FIG. 62. FIG. 63shows a state in which the first housing of the operation portion isremoved from the operation portion of the stent delivery device shown inFIG. 62 and also shows a section of the connector.

The basic construction of the operation portion 250 of this embodimentis the same as that of the operation portion 200 except the constructionof the reverse rotation prevention mechanism 260 of the rotationalroller 61 and that of a part of the connector. Thus the otherconstructions of the operation portion 250 are referred to thedescription of the operation portion 200.

As shown in FIGS. 62 through 64, the operation portion 250 has a housing251. The proximal side and the central portion of the housing 251 arebent and rounded. This configuration allows the housing 251 to be heldeasily and the roller to be operated easily. The housing 251 isconstructed of a first housing 251 a and a second housing 251 b.

The distal portion of a cylindrical connector 255 is fixed to theproximal end of the proximal-side tube 4. The housing 251 of theoperation portion accommodates a sealing mechanism connected to theproximal portion of the connector 255. The sealing mechanism has acylindrical body member 270, having a distal portion, which is fixed tothe proximal portion of the connector 255, a cap member 271 fixed to theproximal end of the cylindrical body member 270, a sealing member 272disposed between the cylindrical body member 270 and the cap member 271,and a rigidity-imparting member-fixing member 273. The sealing member272 has a hole or a slit through which the pulling wire (6 a, 6 b) ispenetrated liquid-tightly and slidably. The proximal portion of therigidity-imparting member 11 is fixed to the rigidity-impartingmember-fixing member 273. The rigidity-imparting member-fixing member273 is fixed to the inside of the cylindrical body member 270. Theabove-described materials can be used to compose the connector. Theabove-described elastic materials are used to compose the sealingmember.

As shown in FIGS. 62 and 64, the housing 251 includes the open portion98 for partly projecting the rotational roller 61, a bearing portion 94a accommodating other end 64 a of the rotating shaft of the roller 61,and a bearing portion 94 b accommodating one end 64 b of the rotatingshaft of the roller 61. Although not shown, the housing 251 has alocking rib. The bearing portions 94 a and 94 b are gourd-shaped andextended in a direction in which they recede from the locking rib.

The reverse rotation prevention mechanism of the operation portion 250of this embodiment is described below.

As shown in FIGS. 62 through 64, the rotational roller 61 has the gearportion 62 which is coaxial therewith and rotates together therewith. Asshown in FIG. 64, the gear portion 62 is provided on a surface oppositeto a surface on which the winding shaft portion 63 of the rotationalroller 61 is provided. Thus the gear portion 62 and the winding shaftportion 63 are partitioned from each other by a wall constructed of therotational roller.

As shown in FIGS. 62 and 63, the reverse rotation prevention mechanism261 is accommodated in the operation portion 250. The reverse rotationprevention mechanism 261 has an engaging portion 264, disposed at aportion opposed to the gear portion 62 of the rotational roller 61,capable of engaging the gear portion, an elastically deformable portion262, and a portion 263 to be mounted on the housing. The housing 251 bhas a first projected portion 252 and a second projected portion 253both formed on the inner surface thereof. The first projected portion252 penetrates into the elastically deformable portion 262 and has anouter configuration corresponding to the inner configuration of theelastically deformable portion 262. More specifically, the inner surfaceof the elastically, deformable portion 262 is circular arc-shaped. Thefirst projected portion 252 is also circular arc-shaped incorrespondence thereto. The portion 263 to be mounted on the housing ofthe reverse rotation prevention mechanism 261 is so configured as to bemounted between the first projected portion 252 and the second projectedportion 253 formed on the inner surface of the housing 251 b. Becausethe accommodation portion 263 of the reverse rotation preventionmechanism 261 is mounted between the first projected portion 252 and thesecond projected portion 253, the rotational roller 61 is incapable ofrotating and urged toward the open portion 58 by the elastic force ofthe elastically deformable portion 262. The collar member 102 has a diskstate rib 103 c. The portion 263 to be mounted on the housing of thereverse rotation prevention mechanism 261 is held at a side surfacethereof by the disk state rib 103 c.

As described above, by pressing the roller 61, the roller can berotated. The roller 61 is rotatable in the direction (pullingwire-winding direction) shown with the arrow of FIG. 63. If an operationof rotating the roller 61 in the opposite direction is performed, onecog of the gear portion 62 and the engaging portion 264 of the reverserotation prevention mechanism 261 engage each other. Thereby therotation of the roller 61 is prevented. Thereby the reverse rotationprevention mechanism prevents the rotation of the roller of the pullingwire winding mechanism in the direction opposite to the pulling wirewinding direction. As shown in FIG. 64, in the operation portion 250,the reverse rotation prevention mechanism 261 is disposed between theinner surface of the housing 251 b and the side surface of therotational roller 61. Therefore the movement of the reverse rotationprevention mechanism 261 in a lateral direction (horizontal direction)is prevented by the inner surface of the housing 251 b and the sidesurface of the rotational roller 61.

The construction of the pulling wire winding mechanism is not limited tothe above-described one, but any pulling wire winding mechanisms capableof winding a wire can be used. The construction of the locking mechanismis not limited to the above-described one, but any locking mechanismscapable of releasably locking the rotation of the pulling wire windingmechanism can be used. The construction of the reverse rotationprevention mechanism is not limited to the above-described one, but itis possible to use any reverse rotation prevention mechanisms capable ofpreventing the roller from rotating in a direction opposite to a pullingwire winding direction.

1. A stent delivery device comprising: a distal-side tube having a guidewire lumen; a proximal-side tube whose distal portion is fixed to aproximal portion of said distal-side tube; a cylindrical member whichencloses a distal side of said distal-side tube and is slidable toward aproximal end of said distal-side tube; a stent housed in saidcylindrical member; and a pulling wire which extends inside saidproximal-side tube, with one end portion thereof fixed to saidcylindrical member, wherein said distal-side tube has a proximal-sideopening which is open at said proximal side of said distal-side tube andcommunicates with said guide wire lumen; and a stent-locking portionwhich is disposed at said distal side of said distal-side tube andcontacts a proximal end of said stent, thus preventing said stent frommoving to said proximal side of said stent delivery device; and saidstent is formed approximately cylindrically, housed in said cylindricalmember, with said stent being compressed in an axial direction thereof,and expands outward and returns to a configuration before said stent iscompressed, when said stent is implanted in an organism; said stentdelivery device further comprising an operation portion, disposed at aproximal portion of said proximal-side tube, which has a pulling wirewinding mechanism for winding said pulling wire and moving saidcylindrical member toward a proximal side of said stent delivery device.2. A stent delivery device according to claim 1, wherein said operationportion has a housing; and said pulling wire winding mechanism has arotational roller for operational use having a portion exposed from saidhousing; and said pulling wire is wound around said rotational roller ata proximal side thereof by rotating said rotational roller.
 3. A stentdelivery device according to claim 1, wherein said operation portion hasa locking mechanism for releasably locking a rotation of said pullingwire winding mechanism.
 4. A stent delivery device according to claim 1,wherein said operation portion has a reverse rotation preventionmechanism for preventing a rotation of said pulling wire windingmechanism in a direction opposite to a pulling wire winding direction.5. A stent delivery device according to claim 1, wherein said pullingwire winding mechanism has a rotational roller for operational use; anda winding shaft portion, having a diameter smaller than that of saidrotational roller for operational use, which is provided coaxially andintegrally with said rotational roller for operational use; and aproximal portion of said pulling wire is fixed to said winding shaftportion.
 6. A stent delivery device according to claim 5, wherein saidoperation portion has a wire winding amount restriction mechanism forrestricting a length of a wire pulled by said pulling wire windingmechanism, and said wire winding amount restriction mechanism isconstructed of a linear member, having a predetermined length, whose oneend is held by said operation portion, an other end of said linearmember is fixed to said winding shaft portion of said rotational rolleror a linear member-winding shaft portion provided separately from saidwinding shaft portion; and after a predetermined amount of said linearmember is wound around said winding shaft portion or around said linearmember-winding shaft portion by a rotation of said rotational roller ina wire-winding direction, said linear member cannot further wound.
 7. Astent delivery device according to claim 6, wherein said wire windingamount restriction mechanism has a bobbin on which said linear member iswound, with one end of said linear member held thereby and which isrotatably accommodated inside said operation portion.
 8. A stentdelivery device according to claim 1, wherein said operation portion hasa connector connected with a proximal portion of said proximal-sidetube; and said connector has a sealing member through which said pullingwire penetrates liquid-tightly.
 9. A stent delivery device according toclaim 1, further comprising a member, for maintaining a position of saidpulling wire, which is disposed on an outer surface of said distal-sidetube and has a passage through which said pulling wire is capable ofpenetrating.
 10. A stent delivery device according to claim 1, furthercomprising a projected portion provided on an outer surface of saiddistal-side tube; and said cylindrical member has a slit which extendsfrom a proximal end thereof toward a distal side thereof and into whichsaid projected portion is capable of moving.
 11. A stent delivery deviceaccording to claim 10, wherein said projected portion is composed of atubular member or a ring-shaped member.
 12. A stent delivery deviceaccording to claim 1, further comprising a movement distance restrictionportion for restricting a movement distance of said cylindrical membertoward a proximal side of said stent delivery device.
 13. A stentdelivery device according to claim 1, wherein said pulling wire windingmechanism has a winding shaft portion; and a collar portion enclosingsaid winding shaft portion, forming an annular space between said collarportion and an outer surface of said winding shaft portion, andpreventing said pulling wire wound around said winding shaft portionfrom becoming loose.
 14. A stent delivery device according to claim 1,further comprising an intermediate tube which encloses a proximal sideof said distal-side tube and a proximal side of said cylindrical memberand is fixed at a proximal portion thereof to a proximal portion of saiddistal-side tube and a distal portion of said proximal-side tube,wherein said intermediate tube encloses said proximal side of saiddistal-side tube and said proximal side of said cylindrical memberwithout preventing said cylindrical member from moving toward saidproximal side of said stent delivery device; one end portion of saidpulling wire is fixed to said cylindrical member inside saidintermediate tube; and said pulling wire passes a space between saidintermediate tube and said distal-side tube and extends into saidproximal-side tube.
 15. A stent delivery device according to claim 1,wherein said distal-side tube has a passage through which said pullingwire is capable of penetrating.
 16. A stent delivery device according toclaim 1, wherein said distal-side tube has a small-diameter portionformed at a distal side thereof; and said stent-locking portion isconstructed of a proximal end of said small-diameter portion.
 17. Astent delivery device according to claim 1, wherein two pulling wiresare provided.
 18. A stent delivery device according to claim 1, whereinsaid operation portion has a wire winding amount restriction mechanismfor restricting a length of a wire pulled by said pulling wire windingmechanism.
 19. A stent delivery device according to claim 18, whereinsaid wire winding amount restriction mechanism includes a projectedportion provided at said rotation roller and a locking portion withwhich a rotational roller provided in said operation portion contactsafter said rotational roller rotates in a predetermined amount in awire-winding direction and which prevents a further rotation of saidrotational roller.
 20. A stent delivery device according to claim 19,wherein a position of a projected portion of said wire winding amountrestriction mechanism can be adjusted in said rotational roller toadjust a rotatable amount of said rotational roller.
 21. A stentdelivery device according to claim 1, wherein an outer diameter of saidproximal-side tube is set smaller than an outer diameter of a portion,having a maximum diameter, which is disposed in a region distal fromsaid proximal-side tube.
 22. A stent delivery device according to claim1, wherein said stent delivery device has a rigidity-imparting memberwhich passes inside said proximal-side tube and penetrates into saidcylindrical member; a distal end of said rigidity-imparting member isfixed to an outer surface of said distal-side tube, and a proximalportion of said rigidity-imparting member is fixed to a proximal portionof said proximal-side tube or said operation portion.
 23. A stentdelivery device according to claim 1, wherein an outer diameter of saidproximal-side tube is set smaller than an outer diameter of a portionwhere said distal-side tube and said proximal-side tube are fixed toeach other.
 24. A stent delivery device according to claim 1, wherein anouter diameter of said proximal-side tube is set smaller than an outerdiameter of said cylindrical member.
 25. A stent delivery deviceaccording to claim 1, wherein said stent delivery device has arigidity-imparting member which passes inside said proximal-side tubeand penetrates into said cylindrical member; a distal end of saidrigidity-imparting member is fixed to an outer surface of saiddistal-side tube, and a proximal portion of said rigidity-impartingmember is fixed to a proximal portion of said proximal-side tube or saidoperation portion.